Swan-Ganz Flow-Directed Multipur. Cath.
FDA 510(k) K803058 · American Edwards Laboratories
510(k) numberK803058
Submission
- Device name
- Swan-Ganz Flow-Directed Multipur. Cath.
- Applicant
- American Edwards Laboratories
Mchenry, IL, US - Received
- December 2, 1980
- Decision date
- January 16, 1981
- 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
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 |
|---|---|---|
| K873485 | Edslab (R) Occlusion Balloon CatheterDQY · Traditional | 12/03/1987SE |
| K872596 | Trantec Disposable Pressure TRANS.53-600/F/F30DRS · Traditional | 09/30/1987SE |
| K872529 | Thermodilution Cardiac Output Computer, Mod. COM-2DXG · Traditional | 09/15/1987SE |
| K870444 | Homepro II Volumetric Infusion PumpFRN · Traditional | 04/17/1987SE |
| K864997 | Medtrac VP Volumetric Infusion PumpFRN · Traditional | 02/27/1987SE |
| K864330 | Shear Force GaugeDXE · Traditional | 01/06/1987SE |
| K862724 | Vein Valve CutterDQY · Traditional | 01/02/1987SE |
| K864155 | Modification of Carpentier-Edwards BioprosthesisDTJ · Traditional | 11/20/1986SE |
| K863596 | Chin-Fogarty Inflation DeviceDXT · Traditional | 11/20/1986SE |
| K863986 | Xenon Light Source for Endoscopic ProceduresHRX · Traditional | 10/31/1986SE |
Questions and answers
When was Swan-Ganz Flow-Directed Multipur. Cath. cleared by the FDA?
Swan-Ganz Flow-Directed Multipur. Cath. (K803058) received a 510(k) decision of Substantially Equivalent on January 16, 1981, 45 days after the submission was received.
What is the product code of K803058?
The FDA product code is LDF – Electrode, Pacemaker, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.3680.