Safpace System
FDA 510(k) K955829 · B.Braun Medical, Inc.
510(k) numberK955829
Submission
- Device name
- Safpace System
- Applicant
- B.Braun Medical, Inc.
Bethlehem, PA, US - Received
- December 26, 1995
- Decision date
- November 18, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)LDF · Special | C.R. Bard, Inc. | 05/15/2025SE |
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| K241199 | Rotatable Connector (5944RL)LDF · Traditional | Shenzhen Launch Electrical Co., Ltd. | 01/23/2025SE |
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| 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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Questions and answers
When was Safpace System cleared by the FDA?
Safpace System (K955829) received a 510(k) decision of Substantially Equivalent on November 18, 1997, 693 days after the submission was received.
What is the product code of K955829?
The FDA product code is LDF – Electrode, Pacemaker, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.3680.