FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
PTI INTRA-ART (TM) PICK-UP WICKS
K Number: K905068
·
Decision Dec 31, 1991
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
270
Applicant Total
19
Review Days
417
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Basic Information
- Device Name
- PTI INTRA-ART (TM) PICK-UP WICKS
- K Number
- K905068
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Pioneering Technologies, Inc.
- Date Received
- November 9, 1990
- Decision Date
- December 31, 1991
- Product Code
- EFQ
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EFQ), ordered by most recent decision date.
NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE
FDA 510(k)
FDA Unclassified
·Unknown
SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S
FDA 510(k)
FDA Unclassified
·Unknown
VITOP DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE
FDA 510(k)
FDA Unclassified
·Unknown
CROSSTEX NON-WOVEN SPONGES
FDA 510(k)
FDA Unclassified
·Unknown
GAUZE, SPONGES, CAT # 11-003
FDA 510(k)
FDA Unclassified
·Unknown
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 |
| K910067 | PTI STERNAL CLOSURE WIRE SUTURE | May 6, 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 |