The following data is part of a premarket notification filed by Mallinckroot, Inc. with the FDA for Copperhead 5 Fr. Pta Catheter, Finch 4 Fr. Pta Catheter.
| Device ID | K983830 |
| 510k Number | K983830 |
| Device Name: | COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | MALLINCKROOT, INC. 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
| Contact | Teresa O'shea |
| Correspondent | Teresa O'shea MALLINCKROOT, INC. 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-30 |
| Decision Date | 1999-04-16 |
| Summary: | summary |