Achieve ST Mapping Catheter, Catheter Connecting Cable
FDA 510(k) K153139 · Medtronic, Inc.
510(k) numberK153139
Submission
- Device name
- Achieve ST Mapping Catheter, Catheter Connecting Cable
- Applicant
- Medtronic, Inc.
Mounds View, MN, US - Received
- October 30, 2015
- Decision date
- May 6, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1220
- Specialty
- Cardiovascular
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| K210313 | EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping CatheterDRF · Traditional | Shanghai Microport EP Medtech Co., Ltd. | 12/30/2022SE |
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| K251744 | Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial…DTM · Special | 01/16/2026SE |
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Questions and answers
When was Achieve ST Mapping Catheter, Catheter Connecting Cable cleared by the FDA?
Achieve ST Mapping Catheter, Catheter Connecting Cable (K153139) received a 510(k) decision of Substantially Equivalent on May 6, 2016, 189 days after the submission was received.
What is the product code of K153139?
The FDA product code is DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording, a Class II (moderate risk) device regulated under 21 CFR 870.1220.