SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS

Catheter, Angioplasty, Peripheral, Transluminal

CLEARSTREAM TECHNOLOGIES, LTD.

The following data is part of a premarket notification filed by Clearstream Technologies, Ltd. with the FDA for Savvy Long And Sleek Peripheral Transluminal Angioplasty (pta) Catheters.

Pre-market Notification Details

• Device ID: K072947
• 510k Number: K072947
• Device Name: SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS
• Classification: Catheter, Angioplasty, Peripheral, Transluminal
• Applicant: CLEARSTREAM TECHNOLOGIES, LTD. 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746
• Contact: Ian P Gordon
• Correspondent: Ian P Gordon; CLEARSTREAM TECHNOLOGIES, LTD. 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746
• Product Code: LIT
• CFR Regulation Number: 870.1250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-10-18
• Decision Date: 2008-02-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00801741132865	K072947	000
00801741132698	K072947	000
00801741132681	K072947	000
00801741132674	K072947	000
00801741132667	K072947	000
00801741132650	K072947	000
00801741132643	K072947	000
00801741132636	K072947	000
00801741132629	K072947	000
00801741132612	K072947	000
00801741132605	K072947	000
00801741132599	K072947	000
00801741132582	K072947	000
00801741132575	K072947	000
00801741132704	K072947	000
00801741132711	K072947	000
00801741132728	K072947	000
00801741132858	K072947	000
00801741132841	K072947	000
00801741132834	K072947	000
00801741132827	K072947	000
00801741132810	K072947	000
00801741132803	K072947	000
00801741132797	K072947	000
00801741132780	K072947	000
00801741132773	K072947	000
00801741132766	K072947	000
00801741132759	K072947	000
00801741132742	K072947	000
00801741132735	K072947	000
00801741132568	K072947	000
00801741132551	K072947	000
00801741132384	K072947	000
00801741132377	K072947	000
00801741132360	K072947	000
00801741132322	K072947	000
00801741132315	K072947	000
00801741132308	K072947	000
00801741132292	K072947	000
00801741132285	K072947	000
00801741132278	K072947	000
00801741132261	K072947	000
00801741132254	K072947	000
00801741132247	K072947	000
00801741132230	K072947	000
00801741132391	K072947	000
00801741132407	K072947	000
00801741132414	K072947	000
00801741132544	K072947	000
00801741132537	K072947	000
00801741132520	K072947	000
00801741132513	K072947	000
00801741132506	K072947	000
00801741132490	K072947	000
00801741132483	K072947	000
00801741132476	K072947	000
00801741132469	K072947	000
00801741132452	K072947	000
00801741132445	K072947	000
00801741132438	K072947	000
00801741132421	K072947	000
00801741132223	K072947	000
00801741133480	K072947	000
00801741133312	K072947	000
00801741133305	K072947	000
00801741133299	K072947	000
00801741133282	K072947	000
00801741133275	K072947	000
00801741133268	K072947	000
00801741133251	K072947	000
00801741133244	K072947	000
00801741133237	K072947	000
00801741133220	K072947	000
00801741133213	K072947	000
00801741133206	K072947	000
00801741133190	K072947	000
00801741133329	K072947	000
00801741133336	K072947	000
00801741133343	K072947	000
00801741133473	K072947	000
00801741133466	K072947	000
00801741133459	K072947	000
00801741133442	K072947	000
00801741133435	K072947	000
00801741133428	K072947	000
00801741133411	K072947	000
00801741133404	K072947	000
00801741133398	K072947	000
00801741133381	K072947	000
00801741133374	K072947	000
00801741133367	K072947	000
00801741133350	K072947	000
00801741133183	K072947	000
00801741133176	K072947	000
00801741133008	K072947	000
00801741132995	K072947	000
00801741132988	K072947	000
00801741132971	K072947	000
00801741132964	K072947	000
00801741132957	K072947	000
00801741132940	K072947	000
00801741132933	K072947	000
00801741132926	K072947	000
00801741132919	K072947	000
00801741132902	K072947	000
00801741132896	K072947	000
00801741132889	K072947	000
00801741133015	K072947	000
00801741133022	K072947	000
00801741133039	K072947	000
00801741133169	K072947	000
00801741133152	K072947	000
00801741133145	K072947	000
00801741133138	K072947	000
00801741133121	K072947	000
00801741133114	K072947	000
00801741133107	K072947	000
00801741133091	K072947	000
00801741133084	K072947	000
00801741133077	K072947	000
00801741133060	K072947	000
00801741133053	K072947	000
00801741133046	K072947	000
00801741132872	K072947	000