The following data is part of a premarket notification filed by Daig Corp. with the FDA for Fast-cath (tm) Intra-cardiac Introducer.
| Device ID | K973840 |
| 510k Number | K973840 |
| Device Name: | FAST-CATH (TM) INTRA-CARDIAC INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | DAIG CORP. 14901 DEVEAU PLACE Minnetonka, MN 55345 -2126 |
| Contact | Dean Bruhn-ding, Rac |
| Correspondent | Dean Bruhn-ding, Rac 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 | 1997-10-08 |
| Decision Date | 1998-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734203227 | K973840 | 000 |
| 05414734203210 | K973840 | 000 |
| 05414734203203 | K973840 | 000 |
| 05414734203142 | K973840 | 000 |
| 05414734203128 | K973840 | 000 |
| 05414734203111 | K973840 | 000 |
| 05414734203067 | K973840 | 000 |