The following data is part of a premarket notification filed by Intec Medical, Inc. with the FDA for Interflo Medical Model Pa3-h Cco/pac Catheter.
| Device ID | K911840 |
| 510k Number | K911840 |
| Device Name: | INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER |
| Classification | Catheter, Flow Directed |
| Applicant | INTEC MEDICAL, INC. C/O BIOMETRIC RESEARCH INST. 1401 WILSON BLVD., SUITE 400 Arlington, VA 22209 |
| Contact | Glenn A Rahmoeller |
| Correspondent | Glenn A Rahmoeller INTEC MEDICAL, INC. C/O BIOMETRIC RESEARCH INST. 1401 WILSON BLVD., SUITE 400 Arlington, VA 22209 |
| Product Code | DYG |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-25 |
| Decision Date | 1991-06-03 |