The following data is part of a premarket notification filed by Spirit Medical Systems, Inc. with the FDA for Dual Purpose Closed Catheter.
| Device ID | K982945 |
| 510k Number | K982945 |
| Device Name: | DUAL PURPOSE CLOSED CATHETER |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | SPIRIT MEDICAL SYSTEMS, INC. 16267 WHITESTONE DR. Parker, CO 80134 |
| Contact | Jeff Sawyer |
| Correspondent | Jeff Sawyer SPIRIT MEDICAL SYSTEMS, INC. 16267 WHITESTONE DR. Parker, CO 80134 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-21 |
| Decision Date | 1998-09-22 |
| Summary: | summary |