FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLUORO-TEX SURGICAL MEMBRANE
K Number: K973178
·
Decision Nov 24, 1997
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
89
Applicant Total
7
Review Days
91
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Basic Information
- Device Name
- FLUORO-TEX SURGICAL MEMBRANE
- K Number
- K973178
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3470
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bridger Biomed, Inc.
- Date Received
- August 25, 1997
- Decision Date
- November 24, 1997
- 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 Bridger Biomed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K003906 | MODIFICATION TO FLUROTEX SURGICAL MESH | Jan 26, 2001 | Substantially Equivalent |
| K003917 | MODIFICATION TO FLUOROTEX II SURGICAL MESH | Jan 26, 2001 | Substantially Equivalent |
| K002351 | FLUOROTEX II SURGICAL MESH | Aug 26, 2000 | Substantially Equivalent |
| K994032 | FLUORO-TEX CARDIOVASCULAR PATCH | Jul 7, 2000 | Substantially Equivalent |
| K984197 | FLUOROTEX SURGICAL MESH | Jan 7, 1999 | Substantially Equivalent |
| K980548 | DURA-PATCH MODEL DP-XXX | May 13, 1998 | Substantially Equivalent |