Balloon Temp. Pacing Catheter
FDA 510(k) K822003 · Ziehm International, Inc.
510(k) numberK822003
Submission
- Device name
- Balloon Temp. Pacing Catheter
- Applicant
- Ziehm International, Inc.
Annapolis, MD, US - Received
- July 8, 1982
- Decision date
- October 15, 1982
- 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 |
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| K902196 | Modified Stick-Gard Safety NeedleFPA · Traditional | 06/26/1990SE |
| K894021 | Mobile X-Ray UnitIZL · Traditional | 09/01/1989SE |
| K894041 | Pump-Ject Syringe with Luer-LockFRN · Traditional | 08/28/1989SE |
| K890620 | Stick-Gard Safety NeedleFMI · Traditional | 02/28/1989SE |
| K882133 | Mammo MIZH · Traditional | 09/19/1988SE |
| K843311 | IV Admin. Set for MVP 1 Infusion PumpFRN · Traditional | 03/13/1985SE |
| K842263 | MTP E.V. Infusion PumpFRN · Traditional | 07/25/1984SE |
| K831407 | Cardiac Output ComputerDXG · Traditional | 10/14/1983SE |
Questions and answers
When was Balloon Temp. Pacing Catheter cleared by the FDA?
Balloon Temp. Pacing Catheter (K822003) received a 510(k) decision of Substantially Equivalent on October 15, 1982, 99 days after the submission was received.
What is the product code of K822003?
The FDA product code is LDF – Electrode, Pacemaker, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.3680.