ONTRAC

Wire, Guide, Catheter

LAKE REGION MFG., INC.

The following data is part of a premarket notification filed by Lake Region Mfg., Inc. with the FDA for Ontrac.

Pre-market Notification Details

• Device ID: K914138
• 510k Number: K914138
• Device Name: ONTRAC
• Classification: Wire, Guide, Catheter
• 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: DQX
• CFR Regulation Number: 870.1330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-09-16
• Decision Date: 1991-12-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
15414734030738	K914138	000
15414734028278	K914138	000
15414734028247	K914138	000
15414734028223	K914138	000
15414734028209	K914138	000
15414734028162	K914138	000
15414734013717	K914138	000
15414734013700	K914138	000
15414734013670	K914138	000