The following data is part of a premarket notification filed by Spectramed, Inc. with the FDA for Heparin Coated Luminal Pacing Catheter.
| Device ID | K875337 |
| 510k Number | K875337 |
| Device Name: | HEPARIN COATED LUMINAL PACING CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard, CA 93030 |
| Contact | Robert L Leavitt |
| Correspondent | Robert L Leavitt SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard, CA 93030 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-30 |
| Decision Date | 1988-05-25 |