The following data is part of a premarket notification filed by Lake Region Mfg., Inc. with the FDA for Insite Steerable Guidewire.
Device ID | K901224 |
510k Number | K901224 |
Device Name: | INSITE STEERABLE GUIDEWIRE |
Classification | Wire, Guide, Catheter |
Applicant | LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318 |
Contact | Blake Immerfall |
Correspondent | Blake Immerfall LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318 |
Product Code | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-14 |
Decision Date | 1990-06-11 |