FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
CARDIOFLON, CARDIOXYL
K Number: K060163
·
Decision Oct 11, 2006
Classifications
1
FEI Numbers
242
Registration Numbers
242
Same Product Code
173
Applicant Total
7
Review Days
261
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Basic Information
- Device Name
- CARDIOFLON, CARDIOXYL
- K Number
- K060163
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.5000
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Peters Surgical
- Date Received
- January 23, 2006
- Decision Date
- October 11, 2006
- Product Code
- GAT
- 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 |
|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | FDA class 2 | General, Plastic Surgery |
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|---|---|---|---|
| K233265 | Monotime and Optime R | Oct 11, 2024 | Substantially Equivalent |
| K232372 | Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) | Jul 12, 2024 | Substantially Equivalent |
| K071281 | UNIRING - ANNULOPLASTY RING WITH SIZERS | Aug 3, 2007 | Substantially Equivalent |
| K060465 | PREMIO | Jan 17, 2007 | Substantially Equivalent |
| K062366 | OPTIME, SINUSORB PGA | Oct 2, 2006 | Substantially Equivalent |
| K052701 | COROLENE | Dec 13, 2005 | Substantially Equivalent |