CHAPERON GUIDING CATHETER

Catheter, Percutaneous

MICROVENTION, INC.

The following data is part of a premarket notification filed by Microvention, Inc. with the FDA for Chaperon Guiding Catheter.

Pre-market Notification Details

• Device ID: K082385
• 510k Number: K082385
• Device Name: CHAPERON GUIDING CATHETER
• Classification: Catheter, Percutaneous
• Applicant: MICROVENTION, INC. 75 COLUMBIA Aliso Viejo, CA 92656 -1408
• Contact: Florin Truuvert
• Correspondent: Mark Job; REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• Product Code: DQY
• CFR Regulation Number: 870.1250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2008-08-19
• Decision Date: 2008-12-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00810170012297	K082385	000
00810170012426	K082385	000
00810170012433	K082385	000
00810170012808	K082385	000
00810170012815	K082385	000
00810170012822	K082385	000
00810170012839	K082385	000
00810170012846	K082385	000
00810170012853	K082385	000
00810170012860	K082385	000
00810170012877	K082385	000
00810170012419	K082385	000
00810170012402	K082385	000
00810170012303	K082385	000
00810170012310	K082385	000
00810170012327	K082385	000
00810170012334	K082385	000
00810170012341	K082385	000
00810170012358	K082385	000
00810170012365	K082385	000
00810170012372	K082385	000
00810170012389	K082385	000
00810170012396	K082385	000
00810170013133	K082385	000
00810170013140	K082385	000
00810170013270	K082385	000
00810170013287	K082385	000
00810170013294	K082385	000
00810170013300	K082385	000
00810170013317	K082385	000
00810170013324	K082385	000
00810170013331	K082385	000
00810170013348	K082385	000
00810170013355	K082385	000
00810170013362	K082385	000
00810170013263	K082385	000
00810170013256	K082385	000
00810170013157	K082385	000
00810170013164	K082385	000
00810170013171	K082385	000
00810170013188	K082385	000
00810170013195	K082385	000
00810170013201	K082385	000
00810170013218	K082385	000
00810170013225	K082385	000
00810170013232	K082385	000
00810170013249	K082385	000
00810170013379	K082385	000