Pioneering Technologies, Inc.
Martinez, CA, US
Pioneering Technologies, Inc. appears in FDA device records in Martinez, CA. FDA records list 19 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Pioneering Technologies, Inc. between 1988 and 1992. The busiest year on record is 1988, with 6. The most recent is 1992, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 6 |
| 1989 | 3 |
| 1990 | 5 |
| 1991 | 3 |
| 1992 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K922025 | ANASTOMART(TM) CORONARY BYPASS GRAFT MARKERS/MODIF | DSY | Substantially Equivalent | |
| K905175 | PTI ANNULOPLASTY RING(STERILE) | KRH | Substantially Equivalent | |
| K905068 | PTI INTRA-ART (TM) PICK-UP WICKS | EFQ | Substantially Equivalent | |
| K910067 | PTI STERNAL CLOSURE WIRE SUTURE | GAQ | Substantially Equivalent | |
| K905067 | PTI ANASTOMARK FLEXIBLE CORONARY BYPASS GRAFT | DSY | Substantially Equivalent | |
| K901815 | MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY | DRE | Substantially Equivalent | |
| K901682 | PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS | DSY | Substantially Equivalent | |
| K901531 | PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE | DNP | Substantially Equivalent | |
| K901575 | REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD | GXY | Substantially Equivalent | |
| K897075 | PTI INTRA-ART(TM) ANSARI SAPHENOUS VEIN HOLDER | DXC | Substantially Equivalent | |
| K894684 | PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT | DWF | Substantially Equivalent | |
| K891786 | PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE) | DWP | Substantially Equivalent | |
| K893436 | MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT | DWS | Substantially Equivalent | |
| K883221 | PTI INTRA-ART INTER MAMM ARTERY PAPAVER INFUS KIT | DWF | Substantially Equivalent | |
| K882981 | PTI INTRA-ART CORONARY ARTERY RETRACTION CLIP | DWS | Substantially Equivalent | |
| K883135 | PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE) | DWS | Substantially Equivalent | |
| K882879 | PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER) | DXC | Substantially Equivalent | |
| K882381 | PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI | KGO | Substantially Equivalent | |
| K874927 | PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET | DWC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- DXCClamp, Vascular
- DWCController, Temperature, Cardiopulmonary Bypass
- DREDilator, Vessel, For Percutaneous Catheterization
- DWPDilator, Vessel, Surgical
- GXYElectrode, Cutaneous
- EFQGauze/Sponge, Internal
- DWSInstruments, Surgical, Cardiovascular
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter
- KRHRing, Annuloplasty
- KGOSurgeon'S Gloves
- GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- DNPThin Layer Chromatography, Ethosuximide
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain