The following data is part of a premarket notification filed by Daig Corp. with the FDA for Modified Labeling To Permanent Lead Introducer.
| Device ID | K894431 |
| 510k Number | K894431 |
| Device Name: | MODIFIED LABELING TO PERMANENT LEAD INTRODUCER |
| 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 | 1989-07-17 |
| Decision Date | 1989-09-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15415067020977 | K894431 | 000 |
| 15415067020960 | K894431 | 000 |
| 15414734204344 | K894431 | 000 |
| 15414734204320 | K894431 | 000 |
| 15414734204085 | K894431 | 000 |