The following data is part of a premarket notification filed by Daig Corp. with the FDA for Fast-cath Intra-cardiac Introducer.
| Device ID | K982187 |
| 510k Number | K982187 |
| Device Name: | FAST-CATH INTRA-CARDIAC INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | DAIG CORP. 14901 DEVEAU PLACE Minnetonka, MN 55345 -2126 |
| Contact | Dean Bruhn-ding |
| Correspondent | Dean Bruhn-ding DAIG CORP. 14901 DEVEAU PLACE Minnetonka, MN 55345 -2126 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-22 |
| Decision Date | 1998-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734203548 | K982187 | 000 |
| 05414734203531 | K982187 | 000 |