TRANSRADIAL ARTERY ACCESS DEVICES

Introducer, Catheter

Teleflex Medical, Inc.

The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Transradial Artery Access Devices.

Pre-market Notification Details

• Device ID: K112554
• 510k Number: K112554
• Device Name: TRANSRADIAL ARTERY ACCESS DEVICES
• Classification: Introducer, Catheter
• Applicant: Teleflex Medical, Inc. 2400 BERNVILLE ROAD Reading, PA 19605
• Contact: Christine Ford
• Correspondent: Christine Ford; Teleflex Medical, Inc. 2400 BERNVILLE ROAD Reading, PA 19605
• Product Code: DYB
• CFR Regulation Number: 870.1340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-09-02
• Decision Date: 2011-11-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30801902190513	K112554	000
30801902002434	K112554	000
40801902124546	K112554	000
30801902008368	K112554	000
30801902008375	K112554	000
30801902008399	K112554	000
30801902001512	K112554	000
30801902001529	K112554	000
30801902001536	K112554	000
30801902001543	K112554	000
30801902001574	K112554	000
30801902001581	K112554	000
30801902001598	K112554	000
40801902124386	K112554	000
40801902124393	K112554	000
20801902190776	K112554	000
20801902190769	K112554	000
20801902190752	K112554	000
20801902190547	K112554	000
20801902190561	K112554	000
20801902190578	K112554	000
20801902190585	K112554	000
20801902190592	K112554	000
20801902190608	K112554	000
20801902190615	K112554	000
20801902190622	K112554	000
20801902190646	K112554	000
20801902190677	K112554	000
20801902190714	K112554	000
20801902190721	K112554	000
20801902190738	K112554	000
20801902190745	K112554	000
40801902124409	K112554	000
40801902124416	K112554	000
30801902066610	K112554	000
30801902066627	K112554	000
30801902066634	K112554	000
30801902077241	K112554	000
30801902077258	K112554	000
30801902077265	K112554	000
30801902077272	K112554	000
30801902077289	K112554	000
30801902077296	K112554	000
30801902077302	K112554	000
30801902077319	K112554	000
30801902077326	K112554	000
30801902077333	K112554	000
30801902077340	K112554	000
30801902066023	K112554	000
30801902066016	K112554	000
30801902066009	K112554	000
40801902124423	K112554	000
40801902124430	K112554	000
40801902124447	K112554	000
40801902124454	K112554	000
40801902124478	K112554	000
40801902124515	K112554	000
40801902124553	K112554	000
40801902124560	K112554	000
40801902124577	K112554	000
40801902124584	K112554	000
40801902124591	K112554	000
40801902124607	K112554	000
40801902124614	K112554	000
40801902124621	K112554	000
30801902077357	K112554	000