The following data is part of a premarket notification filed by Churchill Medical Systems, Inc. with the FDA for Modification To 30 Extension Set.
| Device ID | K021395 |
| 510k Number | K021395 |
| Device Name: | MODIFICATION TO 30 EXTENSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | CHURCHILL MEDICAL SYSTEMS, INC. 87 VENTURE DR. Dover, NH 03820 |
| Contact | Kevin Paluch |
| Correspondent | Kevin Paluch CHURCHILL MEDICAL SYSTEMS, INC. 87 VENTURE DR. Dover, NH 03820 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-02 |
| Decision Date | 2002-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30849884002561 | K021395 | 000 |
| 30849884003728 | K021395 | 000 |
| 30849884003711 | K021395 | 000 |
| 30849884003674 | K021395 | 000 |
| 30849884001915 | K021395 | 000 |
| 30849884001526 | K021395 | 000 |
| 30849884001212 | K021395 | 000 |
| 30849884003162 | K021395 | 000 |
| 30849884002653 | K021395 | 000 |
| 30849884005999 | K021395 | 000 |
| 30849884003759 | K021395 | 000 |
| 30849884000512 | K021395 | 000 |
| 30849884001830 | K021395 | 000 |
| 30849884002127 | K021395 | 000 |
| 30849884003544 | K021395 | 000 |
| 30849884002752 | K021395 | 000 |
| 30849884002707 | K021395 | 000 |
| 30849884001519 | K021395 | 000 |
| 30849884001502 | K021395 | 000 |
| 30849884001397 | K021395 | 000 |
| 30849884001267 | K021395 | 000 |
| 30849884001847 | K021395 | 000 |
| 30849884005982 | K021395 | 000 |