The following data is part of a premarket notification filed by Daig Corp. with the FDA for Daig Collapsible Sterile Sleeve.
| Device ID | K884478 |
| 510k Number | K884478 |
| Device Name: | DAIG COLLAPSIBLE STERILE SLEEVE |
| Classification | Cannula, 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 | DQR |
| CFR Regulation Number | 870.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-25 |
| Decision Date | 1989-02-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15415067009477 | K884478 | 000 |
| 05415067042859 | K884478 | 000 |
| 05415067042873 | K884478 | 000 |
| 05414734026505 | K884478 | 000 |
| 05414734030038 | K884478 | 000 |
| 05414734030052 | K884478 | 000 |
| 05415067009470 | K884478 | 000 |
| 15414734026502 | K884478 | 000 |
| 15414734030035 | K884478 | 000 |
| 15414734030059 | K884478 | 000 |
| 05415067042811 | K884478 | 000 |