Cardio Flow Peripheral Guide Wire
FDA 510(k) K213834 · Cardio Flow Inc.,
510(k) numberK213834
Submission
- Device name
- Cardio Flow Peripheral Guide Wire
- Applicant
- Cardio Flow Inc.,
Mahtomedi, MN, US - Received
- December 9, 2021
- Decision date
- March 18, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire…DQX · Traditional | Merit Medical Ireland, Ltd. | 01/21/2026SE |
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Questions and answers
When was Cardio Flow Peripheral Guide Wire cleared by the FDA?
Cardio Flow Peripheral Guide Wire (K213834) received a 510(k) decision of Substantially Equivalent on March 18, 2022, 99 days after the submission was received.
What is the product code of K213834?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.