Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe
FDA 510(k) K152633 · Edwards Lifesciences, LLC
510(k) numberK152633
Submission
- Device name
- Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe
- Applicant
- Edwards Lifesciences, LLC
Irvine, CA, US - Received
- September 15, 2015
- Decision date
- October 15, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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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|---|---|---|---|
| K252042 | Sync AV II Temporary Pacing CatheterLDF · Traditional | Swift Sync, Inc. | 07/30/2026SE |
| 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 |
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes…LDF · Traditional | C.R. Bard, Inc. | 01/31/2025SE |
| K241199 | Rotatable Connector (5944RL)LDF · Traditional | Shenzhen Launch Electrical Co., Ltd. | 01/23/2025SE |
| K242705 | Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary…LDF · Special | Medtronic, Inc. | 01/17/2025SE |
| 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 |
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Questions and answers
When was Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe cleared by the FDA?
Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe (K152633) received a 510(k) decision of Substantially Equivalent on October 15, 2015, 30 days after the submission was received.
What is the product code of K152633?
The FDA product code is LDF – Electrode, Pacemaker, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.3680.