Pacing Lead Adapter Model Acs 16
FDA 510(k) K781622 · R.E. Brown Co., Inc.
510(k) numberK781622
Submission
- Device name
- Pacing Lead Adapter Model Acs 16
- Applicant
- R.E. Brown Co., Inc.
Mchenry, IL, US - Received
- September 20, 1978
- Decision date
- December 8, 1978
- 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
Other 510(k)s with product code DTD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Biotronik, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K781624 | Pacing Lead Model Bus 860, Bus 890DTB · Traditional | 12/21/1978SE |
| K781627 | Pacing Lead Adapter Model Adb 21DTD · Traditional | 12/08/1978SE |
| K781626 | Pacing Lead Adapter, Acv 14, Acv 23DTD · Traditional | 12/08/1978SE |
| K781625 | Pacing Lead Model MVM 860, MVM 890DTB · Traditional | 12/08/1978SE |
| K781623 | Pacing Models Mum 860, Mum 890DTB · Traditional | 12/08/1978SE |
| K781621 | Pacing Lead Models, Mam 1260 Mam 1290DTB · Traditional | 12/08/1978SE |
| K781620 | Pacing Lead Models, MDM 1060, MDM 1090DTB · Traditional | 12/08/1978SE |
| K781619 | Pacing Lead Models SA, 350, Sam 500DTB · Traditional | 12/08/1978SE |
| K780781 | Stilith Cardiac Pacemakers-M. 60 & 120DXY · Traditional | 07/27/1978SE |
Questions and answers
When was Pacing Lead Adapter Model Acs 16 cleared by the FDA?
Pacing Lead Adapter Model Acs 16 (K781622) received a 510(k) decision of Substantially Equivalent on December 8, 1978, 79 days after the submission was received.
What is the product code of K781622?
The FDA product code is DTD – Pacemaker Lead Adaptor, a Class II (moderate risk) device regulated under 21 CFR 870.3620.