The following data is part of a premarket notification filed by Churchill Medical Systems, Inc. with the FDA for Universal Vial Access Spike With Needleless Connector.
| Device ID | K013949 |
| 510k Number | K013949 |
| Device Name: | UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR |
| Classification | Set, Administration, Intravascular |
| Applicant | CHURCHILL MEDICAL SYSTEMS, INC. 87 VENTURE DR. Dover, NH 03820 |
| Contact | Ketih Paluch |
| Correspondent | Ketih 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 | 2002-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38498840000848 | K013949 | 000 |
| 30849884002523 | K013949 | 000 |
| 30849884002684 | K013949 | 000 |
| 30849884001540 | K013949 | 000 |
| 30849884002530 | K013949 | 000 |
| 30849884003698 | K013949 | 000 |
| 30849884002691 | K013949 | 000 |
| 38498840006208 | K013949 | 000 |