FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE)
K Number: K891786
·
Decision Oct 12, 1989
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
19
Applicant Total
19
Review Days
202
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Basic Information
- Device Name
- PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE)
- K Number
- K891786
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4475
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Pioneering Technologies, Inc.
- Date Received
- March 24, 1989
- Decision Date
- October 12, 1989
- Product Code
- DWP
- 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 |
|---|---|---|---|
| DWP | Dilator, Vessel, Surgical | FDA class 2 | Cardiovascular |
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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 |
| 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 |