Temp. Cardiac Pacing Wire Tme 60/61/65
FDA 510(k) K831695 · Oscor, Inc.
510(k) numberK831695
Submission
- Device name
- Temp. Cardiac Pacing Wire Tme 60/61/65
- Applicant
- Oscor, Inc.
Palm Harbor, FL, US - Received
- May 25, 1983
- Decision date
- October 20, 1983
- 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 |
|---|---|---|
| K210627 | Breezeway IIDYB · Special | 06/03/2021SE |
| K151951 | Destino ReachDYB · Special | 09/22/2015SE |
| K143463 | IS4/DF4 Port PlugDTD · Traditional | 03/19/2015SE |
| K140917 | Introducer, Model Adelante MagnumDYB · Traditional | 07/09/2014SE |
| K140406 | Destino Twist, Steerable Guiding SheathDYB · Special | 04/17/2014SE |
| K130633 | Introducer Sets, Model Adelante RadialDYB · Traditional | 02/13/2014SE |
| K130843 | Safesept Needle Free Transseptal Trocar GuidewireDRC · Traditional | 01/08/2014SE |
| K130104 | Guidewire, Pursuer SeriesDQX · Traditional | 06/13/2013SE |
| K122960 | Steerable Guiding Sheath, Model Adelante DestinoDYB · Traditional | 12/13/2012SE |
| K122958 | Delivery Sheath, Model Adelante BreezewayDYB · Traditional | 12/13/2012SE |
Questions and answers
When was Temp. Cardiac Pacing Wire Tme 60/61/65 cleared by the FDA?
Temp. Cardiac Pacing Wire Tme 60/61/65 (K831695) received a 510(k) decision of Substantially Equivalent on October 20, 1983, 148 days after the submission was received.
What is the product code of K831695?
The FDA product code is LDF – Electrode, Pacemaker, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.3680.