Pti Intra-Artr Reusable Coronary Artery Probe
FDA 510(k) K901531 · Pioneering Technologies, Inc.
510(k) numberK901531
Submission
- Device name
- Pti Intra-Artr Reusable Coronary Artery Probe
- Applicant
- Pioneering Technologies, Inc.
Wheat Ridge, CO, US - Received
- March 22, 1990
- Decision date
- June 20, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DNP – Thin Layer Chromatography, Ethosuximide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3380
- Specialty
- Clinical Toxicology
More from Pioneering Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K922025 | Anastomart(Tm) Coronary Bypass Graft Markers/ModifDSY · Traditional | 09/22/1992SE |
| K905175 | Pti Annuloplasty Ring(Sterile)KRH · Traditional | 02/14/1992SE |
| K905068 | Pti Intra-Art (TM) Pick-Up WicksEFQ · Traditional | 12/31/1991SE |
| K910067 | Pti Sternal Closure Wire SutureGAQ · Traditional | 05/06/1991SE |
| K905067 | Pti Anastomark Flexible Coronary Bypass GraftDSY · Traditional | 03/18/1991SE |
| K901815 | Modified Sterilization of Intra-Art(Tm) CoronaryDRE · Traditional | 07/03/1990SE |
| K901682 | Pti Anastomark(Tm) Coronary Bypass Graft MarkersDSY · Traditional | 07/03/1990SE |
| K901575 | Reusable TENS Paravertebral Pad #641 Back ElectrodGXY · Traditional | 05/02/1990SE |
| K897075 | Pti Intra-Art(Tm) Ansari Saphenous Vein HolderDXC · Traditional | 04/10/1990SE |
| K894684 | Pti Intra-Art Internal Mammary Artery Cannula KitDWF · Traditional | 10/17/1989SE |
Questions and answers
When was Pti Intra-Artr Reusable Coronary Artery Probe cleared by the FDA?
Pti Intra-Artr Reusable Coronary Artery Probe (K901531) received a 510(k) decision of Substantially Equivalent on June 20, 1990, 90 days after the submission was received.
What is the product code of K901531?
The FDA product code is DNP – Thin Layer Chromatography, Ethosuximide, a Class II (moderate risk) device regulated under 21 CFR 862.3380.