The following data is part of a premarket notification filed by Boston Pacific Medical, Inc. with the FDA for 4 Sure Tm Suction Catheters & Kits.
| Device ID | K921851 |
| 510k Number | K921851 |
| Device Name: | 4 SURE TM SUCTION CATHETERS & KITS |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | BOSTON PACIFIC MEDICAL, INC. 636 BEACON ST. UNIT 204 Boston, MA 02215 |
| Contact | Randall Green |
| Correspondent | Randall Green BOSTON PACIFIC MEDICAL, INC. 636 BEACON ST. UNIT 204 Boston, MA 02215 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-17 |
| Decision Date | 1993-07-07 |