FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIOVASCULAR REPAIR PATCH
K Number: K905073
·
Decision Dec 20, 1991
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
89
Applicant Total
29
Review Days
406
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Basic Information
- Device Name
- CARDIOVASCULAR REPAIR PATCH
- K Number
- K905073
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3470
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Impra, Inc.
- Date Received
- November 9, 1990
- Decision Date
- December 20, 1991
- Product Code
- DXZ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | FDA class 2 | Cardiovascular |
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Other Clearances by Impra, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K004012 | IMPRA CARBOFLO EPTFE VASCULAR GRAFTS | May 14, 2001 | Substantially Equivalent |
| K004011 | IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS | Mar 27, 2001 | Substantially Equivalent |
| K991027 | BI-DIRECTIONAL TUNNELER | Apr 22, 1999 | Substantially Equivalent |
| K983769 | DISTAFLO BYPASS GRAFT | Dec 15, 1998 | Substantially Equivalent |
| K983861 | DISTAFLO BYPASS GRAFT | Nov 24, 1998 | Substantially Equivalent |
| K983064 | IMPRA HIGH POROSITY GRAFT | Nov 19, 1998 | Substantially Equivalent |
| K981076 | VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT | May 7, 1998 | Substantially Equivalent |
| K981079 | VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT | May 7, 1998 | Substantially Equivalent |
| K971192 | IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT | Apr 15, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K964877 | IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT | Mar 20, 1997 | Substantially Equivalent - Subject to Tracking Reg. |