The following data is part of a premarket notification filed by Pioneering Technologies, Inc. with the FDA for Pti Intra-artr Reusable Coronary Artery Probe.
| Device ID | K901531 |
| 510k Number | K901531 |
| Device Name: | PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE |
| Classification | Thin Layer Chromatography, Ethosuximide |
| Applicant | PIONEERING TECHNOLOGIES, INC. 3900 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Contact | Wright,phd |
| Correspondent | Wright,phd PIONEERING TECHNOLOGIES, INC. 3900 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Product Code | DNP |
| CFR Regulation Number | 862.3380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-22 |
| Decision Date | 1990-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B040CPH300L1 | K901531 | 000 |
| B040CPH100L1 | K901531 | 000 |
| B040CPH125 | K901531 | 000 |
| B040CPH125L1 | K901531 | 000 |
| B040CPH150 | K901531 | 000 |
| B040CPH150L1 | K901531 | 000 |
| B040CPH175 | K901531 | 000 |
| B040CPH175L1 | K901531 | 000 |
| B040CPH200 | K901531 | 000 |
| B040CPH200L1 | K901531 | 000 |
| B040CPH225 | K901531 | 000 |
| B040CPH225L1 | K901531 | 000 |
| B040CPH250 | K901531 | 000 |
| B040CPH250L1 | K901531 | 000 |
| B040CPH275 | K901531 | 000 |
| B040CPH275L1 | K901531 | 000 |
| B040CPH300 | K901531 | 000 |
| B040CPH10 | K901531 | 000 |