The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Usci Disp. Y-connector W/modified Tuohy-borst Adap.
| Device ID | K890325 |
| 510k Number | K890325 |
| Device Name: | USCI DISP. Y-CONNECTOR W/MODIFIED TUOHY-BORST ADAP |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | C.R. BARD, INC. 1200 TECHNOLOGY PARK DR. P.O. BOX 7025 Billerica, MA 01821 |
| Contact | Janice T Piasecki |
| Correspondent | Janice T Piasecki C.R. BARD, INC. 1200 TECHNOLOGY PARK DR. P.O. BOX 7025 Billerica, MA 01821 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-23 |
| Decision Date | 1989-03-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169002917 | K890325 | 000 |
| 20643169843053 | K890325 | 000 |