The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Savvy Pta Balloon Catheter.
| Device ID | K942094 |
| 510k Number | K942094 |
| Device Name: | CORDIS SAVVY PTA BALLOON CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | CORDIS CORP. P.O. BOX 025700 Miami, FL 33102 |
| Contact | Colleen Hahnen |
| Correspondent | Colleen Hahnen CORDIS CORP. P.O. BOX 025700 Miami, FL 33102 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-02 |
| Decision Date | 1994-11-01 |