CCS Model AV-106 Implantable A-V Data Lead
FDA 510(k) K851897 · Cardiac Control Systems, Inc.
510(k) numberK851897
Submission
- Device name
- CCS Model AV-106 Implantable A-V Data Lead
- Applicant
- Cardiac Control Systems, Inc.
Palm Coast, FL, US - Received
- April 30, 1985
- Decision date
- August 9, 1985
- 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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| 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 |
|---|---|---|
| K971775 | Interim Av Shaped Temporary Pacing Catheter Model INT-AV610LDF · Traditional | 12/29/1997SE |
| K946188 | CCDS Maestro(R) II Series 200 Cadiac PacemakerDXY · Traditional | 05/15/1995ST |
| K950210 | CCS Maestro(R) II Series 200 Models 235 and 227 Cardiac PacemakerDXY · Traditional | 05/03/1995ST |
| K923868 | CCS Maestro II Series 200 Cardiac PacemakerDXY · Traditional | 05/14/1993SE |
| K905824 | Maestro(R) Series 100/200 Cardiac S/Chamb PacemakeDXY · Traditional | 05/16/1991SE |
| K904941 | Maestro Series 100/200 Cardiac Single Chamber PaceDXY · Traditional | 01/03/1991SE |
| K895110 | Maestro Pacemaker Test MagnetDTG · Traditional | 09/26/1989SE |
| K884023 | Maestro(R) Series 100/200 Single Chamber PacemakerDXY · Traditional | 10/17/1988SE |
| K884024 | Polysafe(Tm) Implantable Pacing LeadDTB · Traditional | 10/14/1988SE |
| K883015 | Polysafe Implant. Pacing Leads W/Trabeculok TipDTB · Traditional | 10/06/1988SE |
Questions and answers
When was CCS Model AV-106 Implantable A-V Data Lead cleared by the FDA?
CCS Model AV-106 Implantable A-V Data Lead (K851897) received a 510(k) decision of Substantially Equivalent on August 9, 1985, 101 days after the submission was received.
What is the product code of K851897?
The FDA product code is DTD – Pacemaker Lead Adaptor, a Class II (moderate risk) device regulated under 21 CFR 870.3620.