FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOPATCH BOVINE PERICARDIAL PATCH
K Number: K840756
·
Decision Feb 8, 1985
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
53
Review Days
351
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Basic Information
- Device Name
- BIOPATCH BOVINE PERICARDIAL PATCH
- K Number
- K840756
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Meadox Medicals, Div. Boston Scientific Corp.
- Date Received
- February 23, 1984
- Decision Date
- February 8, 1985
- Product Code
- DQX
- 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Meadox Medicals, Div. Boston Scientific Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K953647 | MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING | May 16, 1997 | Substantially Equivalent |
| K960766 | MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT | Mar 19, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K962433 | MEADOX EXXCEL EPTFE VASCULAR GRAFT | Mar 17, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K961847 | HEMASHIELD VANTAGE (VASCULAR GRAFT | Jan 22, 1997 | Substantially Equivalent - Subject to Tracking Reg. |
| K962342 | HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH | Sep 10, 1996 | Substantially Equivalent |
| K955460 | MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT | May 30, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K952884 | NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER | Feb 21, 1996 | Substantially Equivalent |
| K955349 | HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC | Feb 14, 1996 | Substantially Equivalent |
| K953298 | MS CLASSIQUE BALLOON DIATATION CATHETER | Feb 8, 1996 | Substantially Equivalent |
| K954848 | HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT | Feb 1, 1996 | Substantially Equivalent - Subject to Tracking Reg. |