The following data is part of a premarket notification filed by Churchill Medical Systems, Inc. with the FDA for Pressure Activated Check Valve.
| Device ID | K011888 |
| 510k Number | K011888 |
| Device Name: | PRESSURE ACTIVATED CHECK VALVE |
| Classification | Set, Administration, Intravascular |
| Applicant | CHURCHILL MEDICAL SYSTEMS, INC. 87 VENTURE DR. Dover, NH 03820 |
| Contact | Keith Paluch |
| Correspondent | Keith Paluch CHURCHILL MEDICAL SYSTEMS, INC. 87 VENTURE DR. Dover, NH 03820 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-18 |
| Decision Date | 2001-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30849884001885 | K011888 | 000 |
| 30849884006217 | K011888 | 000 |