DESTINO TWIST, STEERABLE GUIDING SHEATH

Introducer, Catheter

Oscor Inc.

The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Destino Twist, Steerable Guiding Sheath.

Pre-market Notification Details

• Device ID: K140406
• 510k Number: K140406
• Device Name: DESTINO TWIST, STEERABLE GUIDING SHEATH
• Classification: Introducer, Catheter
• Applicant: Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683
• Contact: Tina Strickland
• Correspondent: Tina Strickland; Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683
• Product Code: DYB
• CFR Regulation Number: 870.1340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-02-18
• Decision Date: 2014-04-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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