Heparin Coat Tran Ballo Tip Temp Pac Electrode
FDA 510(k) K852797 · Mansfield Scientific, Inc.
510(k) numberK852797
Submission
- Device name
- Heparin Coat Tran Ballo Tip Temp Pac Electrode
- Applicant
- Mansfield Scientific, Inc.
Mansfield, MA, US - Received
- June 28, 1985
- Decision date
- September 16, 1985
- 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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| K242863 | Bioptimal Bipolar Pacing CatheterLDF · Traditional | Bioptimal International Pte. , Ltd. | 06/15/2025SE |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)LDF · Special | C.R. Bard, Inc. | 05/15/2025SE |
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| K241199 | Rotatable Connector (5944RL)LDF · Traditional | Shenzhen Launch Electrical Co., Ltd. | 01/23/2025SE |
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| K232261 | TME Temporary Myocardial ElectrodeLDF · Traditional | Osypka AG | 04/26/2024SE |
| K190716 | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar…LDF · Traditional | Medtronic | 08/08/2019SE |
| 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 |
More from Medtronic
| 510(k) | Device | Decision |
|---|---|---|
| K865017 | AngioscopeDQX · Traditional | 12/15/1987SE |
| K870186 | Endomyocardial Biopsy DeviceDWZ · Traditional | 02/20/1987SE |
| K855103 | Ciribart Gyudubg CatgeterDQO · Traditional | 02/18/1986SE |
| K853850 | ExplorerDTB · Traditional | 12/04/1985SE |
| K851848 | Percutaneous Transluminal Blood Dilation CatheterLIT · Traditional | 07/19/1985SE |
| K844752 | Transvenous Balloon Tipped(Flow Directed) Temp. PaDTB · Traditional | 01/02/1985SE |
| K841705 | Wedge Pressure Catheter Flow DirectedDYG · Traditional | 07/13/1984SE |
Questions and answers
When was Heparin Coat Tran Ballo Tip Temp Pac Electrode cleared by the FDA?
Heparin Coat Tran Ballo Tip Temp Pac Electrode (K852797) received a 510(k) decision of Substantially Equivalent on September 16, 1985, 80 days after the submission was received.
What is the product code of K852797?
The FDA product code is LDF – Electrode, Pacemaker, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.3680.