TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE

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 Tear-away Sheath Introducer Set With Integral Hemostasis Valve.

Pre-market Notification Details

• Device ID: K934901
• 510k Number: K934901
• Device Name: TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE
• Classification: Introducer, Catheter
• Applicant: THOMAS MEDICAL PRODUCTS, INC. 65 GREAT VALLEY PKWY. Malvern, PA 19355
• Contact: David G Catlin
• Correspondent: David G Catlin; 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: 1993-10-14
• Decision Date: 1994-01-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884450281113	K934901	000
10884450280888	K934901	000
10884450280864	K934901	000
10884450280840	K934901	000
10884450280826	K934901	000
10884450280802	K934901	000
10884450280789	K934901	000
10884450164201	K934901	000
10884450164164	K934901	000
10884450164157	K934901	000
10884450164133	K934901	000
10884450280901	K934901	000
10884450280925	K934901	000
10884450281106	K934901	000
10884450280963	K934901	000
10884450164119	K934901	000
10884450164072	K934901	000
10884450163891	K934901	000
10884450162917	K934901	000
10884450281373	K934901	000
10884450281199	K934901	000
10884450281090	K934901	000
10884450280949	K934901	000
10884450164058	K934901	000
10884450164041	K934901	000
10884450505660	K934901	000
10884450505615	K934901	000
00884450506059	K934901	000
00884450506035	K934901	000
00884450506028	K934901	000
00884450506011	K934901	000
00884450506004	K934901	000
00884450505991	K934901	000
00884450505984	K934901	000
00884450505946	K934901	000
10884450505677	K934901	000
10884450505684	K934901	000
10884450164027	K934901	000
10884450163990	K934901	000
10884450163983	K934901	000
10884450163969	K934901	000
10884450163952	K934901	000
10884450163938	K934901	000
10884450163921	K934901	000
10884450505790	K934901	000
10884450505707	K934901	000
10884450505691	K934901	000
00884450506042	K934901	000
10884450281120	K934901	000
10884450396077	K934901	000
10884450310455	K934901	000
10884450310448	K934901	000
10884450310431	K934901	000
10884450310394	K934901	000
10884450310387	K934901	000
10884450310370	K934901	000
10884450310363	K934901	000
10884450310356	K934901	000
10884450310349	K934901	000
10884450310332	K934901	000
10884450395940	K934901	000
10884450395957	K934901	000
10884450396060	K934901	000
10884450396046	K934901	000
10884450396039	K934901	000
10884450396022	K934901	000
10884450396015	K934901	000
10884450396008	K934901	000
10884450395995	K934901	000
10884450395988	K934901	000
10884450395971	K934901	000
10884450395964	K934901	000
10884450310325	K934901	000
10884450281496	K934901	000
10884450281304	K934901	000
10884450281298	K934901	000
10884450281281	K934901	000
10884450281274	K934901	000
10884450281267	K934901	000
10884450281250	K934901	000
10884450281243	K934901	000
10884450281236	K934901	000
10884450281229	K934901	000
10884450281212	K934901	000
10884450281311	K934901	000
10884450281328	K934901	000
10884450281489	K934901	000
10884450281472	K934901	000
10884450281465	K934901	000
10884450281458	K934901	000
10884450281441	K934901	000
10884450281397	K934901	000
10884450281366	K934901	000
10884450281359	K934901	000
10884450281342	K934901	000
10884450281335	K934901	000
10884450281205	K934901	000