FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PTI STERNAL CLOSURE WIRE SUTURE
K Number: K910067
·
Decision May 6, 1991
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
31
Applicant Total
19
Review Days
117
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Basic Information
- Device Name
- PTI STERNAL CLOSURE WIRE SUTURE
- K Number
- K910067
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4495
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Pioneering Technologies, Inc.
- Date Received
- January 9, 1991
- Decision Date
- May 6, 1991
- Product Code
- GAQ
- 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 |
|---|---|---|---|
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Pioneering Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K922025 | ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIF | Sep 22, 1992 | Substantially Equivalent |
| K905175 | PTI ANNULOPLASTY RING(STERILE) | Feb 14, 1992 | Substantially Equivalent |
| K905068 | PTI INTRA-ART (TM) PICK-UP WICKS | Dec 31, 1991 | Substantially Equivalent |
| K905067 | PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT | Mar 18, 1991 | Substantially Equivalent |
| K901815 | MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY | Jul 3, 1990 | Substantially Equivalent |
| K901682 | PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS | Jul 3, 1990 | Substantially Equivalent |
| K901531 | PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE | Jun 20, 1990 | Substantially Equivalent |
| K901575 | REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD | May 2, 1990 | Substantially Equivalent |
| K897075 | PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN HOLDER | Apr 10, 1990 | Substantially Equivalent |
| K894684 | PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT | Oct 17, 1989 | Substantially Equivalent |