Flexon Temporary Cardiac Conductive Multifilament
FDA 510(k) K855139 · Davis & Geck, Inc.
510(k) numberK855139
Submission
- Device name
- Flexon Temporary Cardiac Conductive Multifilament
- Applicant
- Davis & Geck, Inc.
Danbury, CT, US - Received
- December 23, 1985
- Decision date
- February 26, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LDF – Electrode, Pacemaker, Temporary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3680
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)LDF · Special | C.R. Bard, Inc. | 05/15/2025SE |
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| K173923 | Temporary Cardiac Pacing WireLDF · Traditional | ETHICON, Inc. | 08/02/2018SE |
| K171253 | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar…LDF · Special | Medtronic | 05/25/2017SE |
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Questions and answers
When was Flexon Temporary Cardiac Conductive Multifilament cleared by the FDA?
Flexon Temporary Cardiac Conductive Multifilament (K855139) received a 510(k) decision of Substantially Equivalent on February 26, 1986, 65 days after the submission was received.
What is the product code of K855139?
The FDA product code is LDF – Electrode, Pacemaker, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.3680.