The following data is part of a premarket notification filed by Daig Corp. with the FDA for Daig Vessel Dilator.
| Device ID | K894330 |
| 510k Number | K894330 |
| Device Name: | DAIG VESSEL DILATOR |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| 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 | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-14 |
| Decision Date | 1989-09-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067009272 | K894330 | 000 |
| 15414734008225 | K894330 | 000 |
| 05415067004796 | K894330 | 000 |
| 05415067042774 | K894330 | 000 |
| 05414734025447 | K894330 | 000 |
| 05414734025423 | K894330 | 000 |
| 05414734053730 | K894330 | 000 |
| 05415067004802 | K894330 | 000 |
| 05414734054089 | K894330 | 000 |
| 05415067042651 | K894330 | 000 |
| 05415067042637 | K894330 | 000 |
| 05414734022323 | K894330 | 000 |
| 05415067042590 | K894330 | 000 |
| 15414734022269 | K894330 | 000 |
| 15414734022320 | K894330 | 000 |
| 15415067004809 | K894330 | 000 |
| 15415067004793 | K894330 | 000 |
| 15414734055960 | K894330 | 000 |
| 15414734054086 | K894330 | 000 |
| 15414734053737 | K894330 | 000 |
| 15414734053713 | K894330 | 000 |
| 15414734025444 | K894330 | 000 |
| 15414734025420 | K894330 | 000 |
| 15414734025406 | K894330 | 000 |
| 15414734023907 | K894330 | 000 |
| 15414734023860 | K894330 | 000 |
| 15414734022337 | K894330 | 000 |
| 05415067042576 | K894330 | 000 |