Silicore Semi-Floater
FDA 510(k) K934787 · Electro-Catheter Corp.
510(k) numberK934787
Submission
- Device name
- Silicore Semi-Floater
- Applicant
- Electro-Catheter Corp.
Rahway, NJ, US - Received
- October 5, 1993
- Decision date
- February 24, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code LDF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Medtronic
| 510(k) | Device | Decision |
|---|---|---|
| K934785 | MultipaceLDF · Traditional | 07/27/1995SE |
| K943257 | Tip Deflector (Genesis)DRF · Traditional | 04/19/1995SE |
| K933451 | Open Tip Multi-Electrode Catheter, ModificationDRF · Traditional | 04/19/1995SE |
| K933450 | Closed Tip Multi-Electrode Catheter, ModificationDRF · Traditional | 04/19/1995SE |
| K874154 | Elecath(R) Transesophageal Pacing CatheterKNT · Traditional | 04/29/1988SE |
| K854511 | Elecath Percutaneous Left Atrial Cannulation SetDQX · Traditional | 02/10/1986SE |
| K854975 | Elecath Pulsatile Perfusion PumpKFM · Traditional | 01/15/1986SE |
| K850065 | Elecath Torkfloat Pacing ProbeDTB · Traditional | 04/10/1985SE |
| K850324 | Elecath Open Tip Bipolar Pacing CatheterLDF · Traditional | 03/27/1985SE |
| K844682 | Elecath Cardiac Output ComputerDXG · Traditional | 03/06/1985SE |
Questions and answers
When was Silicore Semi-Floater cleared by the FDA?
Silicore Semi-Floater (K934787) received a 510(k) decision of Substantially Equivalent on February 24, 1995, 507 days after the submission was received.
What is the product code of K934787?
The FDA product code is LDF – Electrode, Pacemaker, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.3680.