Hemashield Knitted Double Velour Cardiovascular Fabric
FDA 510(k) K955349 · Meadox Medicals, Div. Boston Scientific Corp.
510(k) numberK955349
Submission
- Device name
- Hemashield Knitted Double Velour Cardiovascular Fabric
- Applicant
- Meadox Medicals, Div. Boston Scientific Corp.
Oakland, NJ, US - Received
- November 21, 1995
- Decision date
- February 14, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXZ – Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3470
- Specialty
- Cardiovascular
- Implant
- Yes
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More from Celxcel Pty, Ltd.
| 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 |
| K953298 | MS Classique Balloon Diatation CatheterLIT · Traditional | 02/08/1996SE |
| K954848 | Hemashield Microvel Velour Knitted Vascular GraftMAL · Traditional | 02/01/1996ST |
| K953608 | Noprofile Olbert Catheter System Balloon Dilatation CatheterLIT · Traditional | 12/20/1995SE |
Questions and answers
When was Hemashield Knitted Double Velour Cardiovascular Fabric cleared by the FDA?
Hemashield Knitted Double Velour Cardiovascular Fabric (K955349) received a 510(k) decision of Substantially Equivalent on February 14, 1996, 85 days after the submission was received.
What is the product code of K955349?
The FDA product code is DXZ – Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 870.3470.