Wire, Guide, Catheter, Exempt
Cardiovascular · 21 CFR 870.1330
This product code is the class II exempt counterpart of DQX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
34 firms currently registered for this product code
Gilero, Inc
Pittsboro, NC, US
Advanced Lifesciences Pvt. Ltd.
New Delhi, IN
Merit Medical Uk Limited
Earley Reading, GB
Boston Scientific Limited
CORK Munster, IE
Merit Medical Systems, Inc.
South Jordan, UT, US
Dynaflex Technologies
Irvine, CA, US
Merit Medical Asia Company Limited
Tsim Sha Tsui, HK
Epflex Feinwerktechnik Gmbh
DETTINGEN/ERMS Baden-Wurttemberg, DE
Merit Medical Canada Ltd.
Markham Ontario, CA
Boston Scientific Corporation
Saint Paul, MN, US
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Merit Medical Nederland Bv
Maastricht Airport Limburg, NL
Shanghai Int Medical Instruments Co., Ltd.
Shanghai, CN
Jacobs Institute, Inc.
Buffalo, NY, US
Invamed, Inc.
New York, NY, US
Argon Medical Devices Inc.
ATHENS, TX, US
Sterigenics U.s., Llc
Salt Lake City, UT, US
Boston Scientific Corporation
La Aurora Heredia, CR
Sterigenics U.s., Llc
Queensbury, NY, US
Medas, Inc.
Miami, FL, US
Steri-tek
Fremont, CA, US
Beijing Target Medical Technologies Inc.
Beijing, CN
Merit Medical Australia Pty Ltd.
Braiside Victoria, AU
Synergy Health Ireland Ltd
Tullamore Offaly, IE
Lepu Medical Technology (beijing) Co., Ltd
Beijing, CN
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.