The following data is part of a premarket notification filed by Daig Corp. with the FDA for Fast-cath Transseptal Catheter Introducer.
| Device ID | K964518 |
| 510k Number | K964518 |
| Device Name: | FAST-CATH TRANSSEPTAL CATHETER INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | DAIG CORP. 14901 DEVEAU PLACE Minnetonka, MN 55345 -2126 |
| Contact | John C Heinmiller |
| Correspondent | John C Heinmiller 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 | 1996-10-25 |
| Decision Date | 1997-05-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734203654 | K964518 | 000 |
| 05414734203159 | K964518 | 000 |
| 05414734203265 | K964518 | 000 |
| 05414734203319 | K964518 | 000 |
| 05414734203364 | K964518 | 000 |
| 05414734203371 | K964518 | 000 |
| 05414734203401 | K964518 | 000 |
| 05414734203418 | K964518 | 000 |
| 05414734203647 | K964518 | 000 |
| 05414734203098 | K964518 | 000 |