MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT

Catheter, Intravascular, Diagnostic

MERIT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Modification To Softouch Diagnostic Intravascular Cat.

Pre-market Notification Details

• Device ID: K000659
• 510k Number: K000659
• Device Name: MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT
• Classification: Catheter, Intravascular, Diagnostic
• Applicant: MERIT MEDICAL SYSTEMS, INC. 1111 SOUTH VELASCO Angleton, TX 77515
• Contact: Chester Mccoy
• Correspondent: Chester Mccoy; MERIT MEDICAL SYSTEMS, INC. 1111 SOUTH VELASCO Angleton, TX 77515
• Product Code: DQO
• CFR Regulation Number: 870.1200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-02-28
• Decision Date: 2000-03-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884450025321	K000659	000
10884450009908	K000659	000
10884450009892	K000659	000
10884450009885	K000659	000
10884450009878	K000659	000
10884450003104	K000659	000
10884450003098	K000659	000
10884450003081	K000659	000
00884450002612	K000659	000
10884450009915	K000659	000
10884450009922	K000659	000
10884450010140	K000659	000
00884450025154	K000659	000
00884450020548	K000659	000
10884450020439	K000659	000
10884450019020	K000659	000
10884450018986	K000659	000
10884450010829	K000659	000
10884450010683	K000659	000
10884450010676	K000659	000
00884450002605	K000659	000
00884450002599	K000659	000
10884450001407	K000659	000
10884450001391	K000659	000
10884450001384	K000659	000
10884450001377	K000659	000
10884450001360	K000659	000
10884450001353	K000659	000
10884450001346	K000659	000
10884450522728	K000659	000
00884450001417	K000659	000
00884450001424	K000659	000
00884450001431	K000659	000
00884450002582	K000659	000
00884450002575	K000659	000
00884450002568	K000659	000
00884450002551	K000659	000
00884450002544	K000659	000
00884450002537	K000659	000
00884450002520	K000659	000
00884450001448	K000659	000
10884450522711	K000659	000
00884450026984	K000659	000
00884450283134	K000659	000
10884450207427	K000659	000
10884450207175	K000659	000
00884450202500	K000659	000
00884450197691	K000659	000
10884450168131	K000659	000
00884450167243	K000659	000
10884450166076	K000659	000
00884450159682	K000659	000
00884450230039	K000659	000
00884450230046	K000659	000
10884450234799	K000659	000
00884450283059	K000659	000
00884450276952	K000659	000
10884450263836	K000659	000
00884450253847	K000659	000
00884450253823	K000659	000
00884450253755	K000659	000
00884450250655	K000659	000
00884450237403	K000659	000
00884450159675	K000659	000
10884450152727	K000659	000
10884450040475	K000659	000
10884450040444	K000659	000
10884450040437	K000659	000
10884450040420	K000659	000
10884450030278	K000659	000
10884450029616	K000659	000
00884450029114	K000659	000
00884450028940	K000659	000
00884450042519	K000659	000
10884450063382	K000659	000
10884450066376	K000659	000
10884450147808	K000659	000
00884450147795	K000659	000
00884450147788	K000659	000
10884450147778	K000659	000
10884450082598	K000659	000
10884450073473	K000659	000
10884450073428	K000659	000
10884450066529	K000659	000
10884450027070	K000659	000