Merit Heparin-Coated Inqwire Diagnostic Guidewire
FDA 510(k) K140608 · Merit Medical Systems, Inc.
510(k) numberK140608
Submission
- Device name
- Merit Heparin-Coated Inqwire Diagnostic Guidewire
- Applicant
- Merit Medical Systems, Inc.
Galway, IE - Received
- March 10, 2014
- Decision date
- September 12, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
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Questions and answers
When was Merit Heparin-Coated Inqwire Diagnostic Guidewire cleared by the FDA?
Merit Heparin-Coated Inqwire Diagnostic Guidewire (K140608) received a 510(k) decision of Substantially Equivalent on September 12, 2014, 186 days after the submission was received.
What is the product code of K140608?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.