Adapter Cable
FDA 510(k) K050884 · Remington Medical, Inc.
510(k) numberK050884
Submission
- Device name
- Adapter Cable
- Applicant
- Remington Medical, Inc.
Alpharetta, GA, US - Received
- April 7, 2005
- Decision date
- May 19, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTA – Tester, Pacemaker Electrode Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3720
- Specialty
- Cardiovascular
Other 510(k)s with product code DTA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K163008 | CareLink SmartSync Device Manager - Pacing System AnalyzerDTA · Traditional | Medtronic, Inc. | 02/28/2017SE |
| K101982 | Merlin Psa Patient Cable Ex 3150, Cable Adapter EX3170, M Adapter EX3180DTA · Traditional | St Jude Medical, Crmd | 12/21/2010SE |
| K073230 | Models Era 300 and 3105 Pacing System AnalyzersDTA · Special | Biotronik, Inc. | 12/20/2007SE |
| K033613 | Modification to Era 300 Dual Chamber Pacing System AnalyzerDTA · Special | Biotronik, Inc. | 12/08/2003SE |
| K022360 | Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000 Charger; Era 3000…DTA · Traditional | Biotronik, Inc. | 01/27/2003SE |
| K933069 | Model EP-2 Clinical StimulatorDTA · Traditional | Ep Medical, Inc. | 10/21/1993SE |
| K812104 | Siemens-Elema Psa 376DTA · Traditional | Siemens Corp. | 12/02/1981SE |
| K791380 | Va 1000DTA · Traditional | Vitatron Medical BV | 09/19/1979SE |
| K790503 | Cardiotest 2200DTA · Traditional | Cardiac Pacemakers, Inc. | 05/17/1979SE |
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| K241583 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger…DPW · Special | 08/30/2024SE |
| K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek ChargerDPW · Traditional | 01/27/2022SE |
| K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek ChargerDPW · Traditional | 10/07/2021SE |
| K191315 | Remington Medical, Inc. Automatic Cutting Needle (NAC)KNW · Traditional | 07/12/2019SE |
| K150266 | Remington Medical Inc. Tuohy Epidural NeedlesBSP · Traditional | 06/04/2015SE |
| K130282 | Remington Medical Centrefire 22 Biopsy InstrumentKNW · Traditional | 05/13/2013SE |
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| K990428 | Drainage BagEXF · Traditional | 08/12/1999SE |
| K983621 | Needle GuideIZH · Traditional | 11/03/1998SE |
Questions and answers
When was Adapter Cable cleared by the FDA?
Adapter Cable (K050884) received a 510(k) decision of Substantially Equivalent on May 19, 2005, 42 days after the submission was received.
What is the product code of K050884?
The FDA product code is DTA – Tester, Pacemaker Electrode Function, a Class II (moderate risk) device regulated under 21 CFR 870.3720.