CROSSOVER

Introducer, Catheter

THOMAS MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Thomas Medical Products, Inc. with the FDA for Crossover.

Pre-market Notification Details

• Device ID: K083269
• 510k Number: K083269
• Device Name: CROSSOVER
• Classification: Introducer, Catheter
• Applicant: THOMAS MEDICAL PRODUCTS, INC. 65 GREAT VALLEY PKWY. Malvern, PA 19355
• Contact: Tim Stoudt
• Correspondent: Tim Stoudt; THOMAS MEDICAL PRODUCTS, INC. 65 GREAT VALLEY PKWY. Malvern, PA 19355
• Product Code: DYB
• CFR Regulation Number: 870.1340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-11-05
• Decision Date: 2009-02-03
• Summary: summary