The following data is part of a premarket notification filed by Daig Corp. with the FDA for Daig Percutaneous Catheter Intro. & Removable Hemo.
| Device ID | K894343 |
| 510k Number | K894343 |
| Device Name: | DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO |
| Classification | Introducer, Catheter |
| Applicant | DAIG CORP. 14901 DEVEAU PLACE Minnetonka, MN 55345 -2126 |
| Contact | J Fleischhacker |
| Correspondent | J Fleischhacker 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 | 1989-07-14 |
| Decision Date | 1989-09-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15415067009231 | K894343 | 000 |
| 15414734053959 | K894343 | 000 |
| 15414734052518 | K894343 | 000 |
| 15414734052495 | K894343 | 000 |
| 15414734052471 | K894343 | 000 |
| 15414734052457 | K894343 | 000 |
| 15414734052433 | K894343 | 000 |
| 15414734052419 | K894343 | 000 |
| 15414734052396 | K894343 | 000 |
| 15414734027035 | K894343 | 000 |
| 15414734026618 | K894343 | 000 |
| 15414734026496 | K894343 | 000 |
| 15414734023976 | K894343 | 000 |
| 15414734216910 | K894343 | 000 |
| 15414734216934 | K894343 | 000 |
| 15415067009149 | K894343 | 000 |
| 15415067002997 | K894343 | 000 |
| 15414734217030 | K894343 | 000 |
| 15414734217023 | K894343 | 000 |
| 15414734217016 | K894343 | 000 |
| 15414734217009 | K894343 | 000 |
| 15414734216996 | K894343 | 000 |
| 15414734216989 | K894343 | 000 |
| 15414734216972 | K894343 | 000 |
| 15414734216965 | K894343 | 000 |
| 15414734216958 | K894343 | 000 |
| 15414734216941 | K894343 | 000 |
| 15414734021606 | K894343 | 000 |