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This document is a 510(k) summary submitted to the FDA for the SilverHawk Peripheral Plaque Excision System, detailing its classification, predicate device, safety, effectiveness, and regulatory compliance.

How to fill out special 510k silverhawkth peripheral

How to fill out Special 510(k) SilverHawkTh Peripheral Plaque Excision System

1. Step 1: Gather necessary documentation and materials required for the application.
2. Step 2: Ensure compliance with the FDA's requirements for the Special 510(k) submission.
3. Step 3: Complete the 510(k) application form accurately with product details.
4. Step 4: Provide performance data including any new safety and effectiveness data.
5. Step 5: Include labeling information that meets FDA guidelines.
6. Step 6: Prepare a summary of technical information including design and manufacturing specifications.
7. Step 7: Submit the application through the FDA's electronic submission system.
8. Step 8: Respond to any additional requests for information from the FDA if needed.

Who needs Special 510(k) SilverHawkTh Peripheral Plaque Excision System?

1. Healthcare providers performing peripheral interventions.
2. Patients suffering from peripheral artery disease (PAD) requiring plaque excision.
3. Clinics and hospitals specializing in vascular surgery.
4. Medical professionals seeking advanced tools for vascular procedures.

People Also Ask about

How long does 501k approval take?

The focus of the 510(k) process is to prove something called 'substantial equivalence'. In other words, the aim of the game is to prove to the FDA that the medical device you want to bring to market is broadly similar to another device that's already on the market, known as a predicate device.

What is the 501k process?

FDA Clearance. A 510(k) is a premarket submission made to the FDA. It is called a 510(k) because it refers to that section of the Food, Drug and Cosmetic Act. It is the regulatory pathway mostly utilized for Class II devices that hope to be substantially equivalent to another device which is currently legally marketed.

What does 510 K clearance mean?

It's important to note that clearance under the 510(k) pathway does not indicate that the FDA has approved the device but rather that the FDA has determined the device is equivalent to a similar device already on the market.

Is 510 K the same as FDA approval?

The FDA 510(k) Program is occasionally referred to as premarket notification. It allows a new medical device to gain FDA approval by establishing a set of similarities to a current medical device that is already on the market.

What does 501k clearance mean?

Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Applicants with outstanding review issues will be notified within 100 days.

What is the 510k process?

Domestic manufacturers introducing a device to the U.S. market; Finished device manufacturers must submit a 510(k) if they manufacture a device ing to their own specifications and market it in the U.S. Accessories to finished devices that are sold to the end user are also considered finished devices.

For pdfFiller’s FAQs

What is Special 510(k) SilverHawkTh Peripheral Plaque Excision System?

The Special 510(k) SilverHawkTh Peripheral Plaque Excision System is a regulatory pathway provided by the FDA that allows manufacturers to make modifications to previously cleared devices, ensuring that safety and effectiveness are maintained while streamlining the review process.

Who is required to file Special 510(k) SilverHawkTh Peripheral Plaque Excision System?

Manufacturers of the SilverHawkTh Peripheral Plaque Excision System or similar devices, who intend to make changes that do not significantly affect the safety or effectiveness of the device, are required to file a Special 510(k).

How to fill out Special 510(k) SilverHawkTh Peripheral Plaque Excision System?

To fill out a Special 510(k), manufacturers must complete the appropriate FDA forms, including a summary of safety and effectiveness, device description, and details about the modifications being made, along with supporting documentation.

What is the purpose of Special 510(k) SilverHawkTh Peripheral Plaque Excision System?

The purpose of the Special 510(k) is to provide a streamlined process for manufacturers to submit modifications to existing devices that are intended to enhance device performance or address safety concerns without requiring a full premarket submission.

What information must be reported on Special 510(k) SilverHawkTh Peripheral Plaque Excision System?

The information required on a Special 510(k) submission includes the device's name and identification, the intended use, details of the modifications, supporting data or evidence of safety and effectiveness, and comparisons to the previously cleared version.