The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Floswitch(r) Hp.
| Device ID | K913871 |
| 510k Number | K913871 |
| Device Name: | FLOSWITCH(R) HP |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | BOSTON SCIENTIFIC CORP. 2710 ORCHARD PKWY. San Jose, CA 95134 |
| Contact | Pamela L Cadorette |
| Correspondent | Pamela L Cadorette BOSTON SCIENTIFIC CORP. 2710 ORCHARD PKWY. San Jose, CA 95134 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-28 |
| Decision Date | 1991-11-25 |