FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KENSEY NASH MACROPORE SHIELD
K Number: K071695
·
Decision Dec 31, 2007
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
335
Applicant Total
19
Review Days
194
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Basic Information
- Device Name
- KENSEY NASH MACROPORE SHIELD
- K Number
- K071695
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kensey Nash Corp.
- Date Received
- June 20, 2007
- Decision Date
- December 31, 2007
- Product Code
- FTL
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Kensey Nash Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K103787 | MEDEOR MATRIX | Feb 7, 2011 | Substantially Equivalent |
| K091192 | KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX | Nov 2, 2009 | Substantially Equivalent |
| K091499 | MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) | Oct 22, 2009 | Substantially Equivalent |
| K090919 | KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE | Oct 2, 2009 | Substantially Equivalent |
| K073519 | QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 | Mar 28, 2008 | Substantially Equivalent |
| K072384 | MODIFICATION TO COPIOS BONE VOID FILLER SPONGE & PASTE | Sep 21, 2007 | Substantially Equivalent |
| K072195 | THROMCAT THROMBECTOMY CATHETER SYSTEM | Aug 23, 2007 | Substantially Equivalent |
| K071237 | COPIOS BONE VOID FILLER SPONGE AND PASTE | Jun 1, 2007 | Substantially Equivalent |
| K062870 | TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 | Oct 20, 2006 | Substantially Equivalent |
| K061772 | TRIACTIV FX EMBOLIC PROTECTION SYSTEM | Jul 11, 2006 | Substantially Equivalent |