The following data is part of a premarket notification filed by Churchill Medical Systems, Inc. with the FDA for Vented Vial Access Device.
| Device ID | K013950 |
| 510k Number | K013950 |
| Device Name: | VENTED VIAL ACCESS DEVICE |
| 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 | 2001-11-30 |
| Decision Date | 2002-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30849884002516 | K013950 | 000 |
| 30849884001991 | K013950 | 000 |
| 30849884001144 | K013950 | 000 |
| 30849884003667 | K013950 | 000 |
| 30849884003650 | K013950 | 000 |
| 30849884003643 | K013950 | 000 |
| 38498840006192 | K013950 | 000 |
| 38498840006185 | K013950 | 000 |
| 38498840006178 | K013950 | 000 |