SavvyWire

Wire, Guide, Catheter

Opsens Inc.

The following data is part of a premarket notification filed by Opsens Inc. with the FDA for Savvywire.

Pre-market Notification Details

• Device ID: K213854
• 510k Number: K213854
• Device Name: SavvyWire
• Classification: Wire, Guide, Catheter
• Applicant: Opsens Inc. 750 Boulevard Du Parc Technologique Québec, CA G1P 4S3
• Contact: Marc Chaunet
• Correspondent: Christina Henza; Ultra Lifescience Solutions, Inc. 2811 Milton Ave, #409 Janesville, WI 53545
• Product Code: DQX
• Subsequent Product Code: DXO
• Subsequent Product Code: LDF
• CFR Regulation Number: 870.1330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-12-10
• Decision Date: 2022-09-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07540184130023	K213854	000
07540184130016	K213854	000