The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Maxi Ld Pta Balloon Catheter.
| Device ID | K963000 |
| 510k Number | K963000 |
| Device Name: | MAXI LD PTA BALLOON CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Tamara Yount |
| Correspondent | Tamara Yount CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-02 |
| Decision Date | 1997-02-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032002407 | K963000 | 000 |
| 20705032002216 | K963000 | 000 |
| 20705032002209 | K963000 | 000 |
| 20705032002193 | K963000 | 000 |
| 20705032002179 | K963000 | 000 |
| 20705032002162 | K963000 | 000 |
| 20705032002148 | K963000 | 000 |
| 20705032002131 | K963000 | 000 |
| 20705032002094 | K963000 | 000 |
| 20705032002087 | K963000 | 000 |
| 20705032002070 | K963000 | 000 |
| 20705032002223 | K963000 | 000 |
| 20705032002230 | K963000 | 000 |
| 20705032002247 | K963000 | 000 |
| 20705032002391 | K963000 | 000 |
| 20705032002384 | K963000 | 000 |
| 20705032002377 | K963000 | 000 |
| 20705032002339 | K963000 | 000 |
| 20705032002315 | K963000 | 000 |
| 20705032002308 | K963000 | 000 |
| 20705032002285 | K963000 | 000 |
| 20705032002278 | K963000 | 000 |
| 20705032002261 | K963000 | 000 |
| 20705032002254 | K963000 | 000 |
| 20705032002063 | K963000 | 000 |