Key Vascular Booties
FDA 510(k) K896472 · Key Surgical, Inc.
510(k) numberK896472
Submission
- Device name
- Key Vascular Booties
- Applicant
- Key Surgical, Inc.
Minneapolis, MN, US - Received
- November 13, 1989
- Decision date
- December 14, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MAW – Marker, Suture Identification
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
More from Key Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K150532 | Universal Light Handle Cover, Light Handle CoverFTA · Traditional | 09/22/2015SE |
| K151222 | Cautery Tip CleanerGEI · Traditional | 05/22/2015SE |
| K910328 | Key Comfort GripsFSM · Traditional | 03/06/1991SE |
| K896676 | Key Vascular LoopsKDC · Traditional | 02/27/1990SE |
| K895591 | Silicone Instrument ShodsGDJ · Traditional | 10/20/1989SE |
Questions and answers
When was Key Vascular Booties cleared by the FDA?
Key Vascular Booties (K896472) received a 510(k) decision of Substantially Equivalent on December 14, 1989, 31 days after the submission was received.
What is the product code of K896472?
The FDA product code is MAW – Marker, Suture Identification, a Class I (low risk) device regulated under 21 CFR 878.4800.