A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH Pace.
FDA 510(k) K902889 · Biotronik, GmbH & Co.
510(k) numberK902889
Submission
- Device name
- A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH Pace.
- Applicant
- Biotronik, GmbH & Co.
Lake Oswego, OR, US - Received
- July 2, 1990
- Decision date
- August 23, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTD – Pacemaker Lead Adaptor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3620
- Specialty
- Cardiovascular
- Implant
- Yes
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|---|---|---|---|
| K143463 | IS4/DF4 Port PlugDTD · Traditional | Oscor, Inc. | 03/19/2015SE |
| K132008 | 6981M Lead Extender Kit, 6984M Lead Extender Kit, 6986M Lead Extender Kit, 5866-24M Lead…DTD · Special | Medtronic, Inc. | 07/30/2013SE |
| K041574 | Cpi Lead Adapters, Models 6017, 6018 and 6020DTD · Special | Guidant Corporation | 07/12/2004SE |
| K031164 | Pacing Lead Adaptors, Bipolar, Models Ilink-Bis, Ilink-BlvDTD · Special | Oscor, Inc. | 06/19/2003ST |
| K024156 | Pacing Lead Extensions, Bipolar, Pacing Lead Adaptors, Unipolar/Bipolar,Pacing Lead…DTD · Special | Oscor, Inc. | 01/14/2003SE |
| K010787 | Pacing Lead Bipolar Adapters and ExtensionsDTD · Traditional | Oscor, Inc. | 05/22/2001SE |
| K003454 | A1-CS-SB Y-Adapter, Model 124 871DTD · Special | Biotronik, Inc. | 01/18/2001ST |
| K000210 | Modification to Model 5866-37M Lead Adaptor KitDTD · Special | Medtronic Vascular | 02/23/2000ST |
| K982220 | Model 2872 Bipolar Lead Adaptor KitDTD · Traditional | Medtronic Vascular | 10/15/1998ST |
| K971930 | Bk-N Sealing CapDTD · Traditional | Biotronik, Inc. | 08/14/1997PT |
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|---|---|---|
| K261074 | Biomonitor IV (471155)MXD · Special | 05/01/2026SE |
| K250706 | Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…LIT · Special | 04/04/2025SE |
| K242969 | Pantera Pro; Pantera LEOLOX · Special | 10/25/2024SE |
| K240787 | Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool…DQY · Traditional | 09/12/2024SE |
| K241711 | Oscar Peripheral Multifunctional Catheter systemLIT · Special | 07/11/2024SE |
| K230375 | Biomonitor IVMXD · Traditional | 05/19/2023SE |
| K222065 | Passeo-35 Xeo Peripheral Dilatation CatheterLIT · Traditional | 02/16/2023SE |
| K221856 | BIOMONITOR IIIm, BIOMONITOR IIIMXD · Special | 07/27/2022SE |
| K222037 | Selectra Lead Implantation SystemDQY · Special | 07/19/2022SE |
| K214038 | Oscar Peripheral Multifunctional Catheter systemLIT · Traditional | 07/06/2022SE |
Questions and answers
When was A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH Pace. cleared by the FDA?
A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH Pace. (K902889) received a 510(k) decision of Substantially Equivalent on August 23, 1990, 52 days after the submission was received.
What is the product code of K902889?
The FDA product code is DTD – Pacemaker Lead Adaptor, a Class II (moderate risk) device regulated under 21 CFR 870.3620.