The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Owens Catheter.
| Device ID | K896520 |
| 510k Number | K896520 |
| Device Name: | OWENS CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | BOSTON SCIENTIFIC CORP. 2710 ORCHARD PKWY. San Jose, CA 95134 |
| Contact | Leo L Basta |
| Correspondent | Leo L Basta BOSTON SCIENTIFIC CORP. 2710 ORCHARD PKWY. San Jose, CA 95134 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-15 |
| Decision Date | 1991-03-25 |