The following data is part of a premarket notification filed by Boston Scientific, Target with the FDA for Boston Scientific/target Sentry Occlusion Balloon Catheter.
| Device ID | K993292 |
| 510k Number | K993292 |
| Device Name: | BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont, CA 94538 |
| Contact | Gowan Lee |
| Correspondent | Gowan Lee BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont, CA 94538 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-01 |
| Decision Date | 2000-03-23 |
| Summary: | summary |