Roadrunner Extra Support Wire Guide
FDA 510(k) K183467 · Cook Incorporated
510(k) numberK183467
Submission
- Device name
- Roadrunner Extra Support Wire Guide
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- December 14, 2018
- Decision date
- January 11, 2019
- 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 Roadrunner Extra Support Wire Guide cleared by the FDA?
Roadrunner Extra Support Wire Guide (K183467) received a 510(k) decision of Substantially Equivalent on January 11, 2019, 28 days after the submission was received.
What is the product code of K183467?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.