The following data is part of a premarket notification filed by Seigla Medical, Inc. with the FDA for Liquid 061 Guide Catheter Extension, Liquid 071 Guide Catheter Extension.
| Device ID | K220691 |
| 510k Number | K220691 |
| Device Name: | LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension |
| Classification | Catheter, Percutaneous |
| Applicant | Seigla Medical, Inc. 7688 5th Street SE Buffalo, MN 55313 |
| Contact | Chad J. Kugler |
| Correspondent | Craig R. Schlawin Seigla Medical, Inc. 7688 5th Street SE Buffalo, MN 55313 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-09 |
| Decision Date | 2022-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850012180036 | K220691 | 000 |
| 00850012180029 | K220691 | 000 |
| 00850012180012 | K220691 | 000 |
| 00850012180005 | K220691 | 000 |