Hemashield Microvel Velour Knitted Vascular Graft
FDA 510(k) K954848 · Meadox Medicals, Div. Boston Scientific Corp.
510(k) numberK954848
Submission
- Device name
- Hemashield Microvel Velour Knitted Vascular Graft
- Applicant
- Meadox Medicals, Div. Boston Scientific Corp.
Oakland, NJ, US - Received
- October 23, 1995
- Decision date
- February 1, 1996
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Traditional 510(k)
Device classification
- Product code
- MAL – Graft, Vascular, Synthetic/Biologic Composite
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3450
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code MAL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K122612 | Hemashield Woven Double Velour Vascular Graft Model M00202175XXXXX; M00202166XXXXXMAL · Traditional | Maquet Cardiovascular, LLC | 09/10/2012SE |
| K103080 | Albograft Vascular ProsthesisMAL · Traditional | LeMaitre Vascular, Inc. | 01/19/2011SE |
| K093231 | Albograft Vascular ProsthesisMAL · Traditional | LeMaitre Vascular, Inc. | 01/14/2010SE |
| K052302 | Hemashield Platinum Woven Double Velour Taaa Graft ConfigurationMAL · Special | Boston Scientific Corp | 09/12/2005SE |
| K021213 | Modification to Hemashield Platinum Woven/Microvel Double Velour Vascular GraftsMAL · Special | Boston Scientific Corp | 04/19/2002SE |
More from Boston Scientific Corp
| 510(k) | Device | Decision |
|---|---|---|
| K953647 | MS Classique Balloon Catheter W/Hydropass CoatingLIT · Traditional | 05/16/1997SE |
| K960766 | Meadox Medicals, Inc. Expanded PTFE Vascular GraftDYF · Traditional | 03/19/1997ST |
| K962433 | Meadox Exxcel Eptfe Vascular GraftDSY · Traditional | 03/17/1997ST |
| K961847 | Hemashield Vantage (Vascular GraftDSY · Traditional | 01/22/1997ST |
| K962342 | Hemashield Finesse Ultra-Thin, Knitted Cardiovascular PatchDXZ · Traditional | 09/10/1996SE |
| K955460 | Meadox Medicals, Inc., Expanded & Externally Supported Expanded PTFE Vascular GraftDSY · Traditional | 05/30/1996ST |
| K952884 | Noprofile Olbert Catheter System Balloon Dilatation CatheterLIT · Traditional | 02/21/1996SE |
| K955349 | Hemashield Knitted Double Velour Cardiovascular FabricDXZ · Traditional | 02/14/1996SE |
| K953298 | MS Classique Balloon Diatation CatheterLIT · Traditional | 02/08/1996SE |
| K953608 | Noprofile Olbert Catheter System Balloon Dilatation CatheterLIT · Traditional | 12/20/1995SE |
Questions and answers
When was Hemashield Microvel Velour Knitted Vascular Graft cleared by the FDA?
Hemashield Microvel Velour Knitted Vascular Graft (K954848) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on February 1, 1996, 101 days after the submission was received.
What is the product code of K954848?
The FDA product code is MAL – Graft, Vascular, Synthetic/Biologic Composite, a Class II (moderate risk) device regulated under 21 CFR 870.3450.