Pacel(Tm) Flow Directed Pacing Catheter
FDA 510(k) K914185 · Daig Corp.
510(k) numberK914185
Submission
- Device name
- Pacel(Tm) Flow Directed Pacing Catheter
- Applicant
- Daig Corp.
Minnetonka, MN, US - Received
- September 18, 1991
- Decision date
- January 27, 1992
- 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
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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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| K982299 | Spyglass 5 FR Angiographic CatheterDQO · Traditional | 10/19/1998SE |
| K982187 | Fast-Cath Intra-Cardiac IntroducerDYB · Traditional | 09/16/1998SE |
| K973840 | Fast-Cath (TM) Intra-Cardiac IntroducerDYB · Traditional | 05/21/1998SE |
| K964518 | Fast-Cath Transseptal Catheter IntroducerDYB · Traditional | 05/14/1997SE |
| K965249 | Spyglass Angiographic CatheterDQO · Traditional | 02/21/1997SE |
| K962805 | Spyglass Angiographic CatheterDQO · Traditional | 10/15/1996SE |
| K954317 | Diag Fast-Cath Duo & Trio Removable Hemostasis Adapters W/Sideports & 3-WAY StopcocksDYB · Traditional | 11/28/1995SE |
| K944284 | ControlDQO · Traditional | 03/03/1995SE |
Questions and answers
When was Pacel(Tm) Flow Directed Pacing Catheter cleared by the FDA?
Pacel(Tm) Flow Directed Pacing Catheter (K914185) received a 510(k) decision of Substantially Equivalent on January 27, 1992, 131 days after the submission was received.
What is the product code of K914185?
The FDA product code is LDF – Electrode, Pacemaker, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.3680.