The following data is part of a premarket notification filed by Lake Region Mfg., Inc. with the FDA for Isolate Infusion Cathetr System.
| Device ID | K913517 |
| 510k Number | K913517 |
| Device Name: | ISOLATE INFUSION CATHETR SYSTEM |
| Classification | Catheter, Percutaneous |
| Applicant | LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Paul Kohl |
| Correspondent | Paul Kohl LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-07 |
| Decision Date | 1991-11-05 |