Pacing Lead Adaptors, Bipolar, Models Ilink-Bis, Ilink-Blv
FDA 510(k) K031164 · Oscor, Inc.
510(k) numberK031164
Submission
- Device name
- Pacing Lead Adaptors, Bipolar, Models Ilink-Bis, Ilink-Blv
- Applicant
- Oscor, Inc.
Palm Harbor, FL, US - Received
- April 14, 2003
- Decision date
- June 19, 2003
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Special 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 |
| 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 |
| K970388 | A1-A,ABP,B,MBP, Lead Connectors; Peh Adapter SleeveDTD · Traditional | Biotronik, Inc. | 08/14/1997PT |
More from Biotronik, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K210627 | Breezeway IIDYB · Special | 06/03/2021SE |
| K151951 | Destino ReachDYB · Special | 09/22/2015SE |
| K143463 | IS4/DF4 Port PlugDTD · Traditional | 03/19/2015SE |
| K140917 | Introducer, Model Adelante MagnumDYB · Traditional | 07/09/2014SE |
| K140406 | Destino Twist, Steerable Guiding SheathDYB · Special | 04/17/2014SE |
| K130633 | Introducer Sets, Model Adelante RadialDYB · Traditional | 02/13/2014SE |
| K130843 | Safesept Needle Free Transseptal Trocar GuidewireDRC · Traditional | 01/08/2014SE |
| K130104 | Guidewire, Pursuer SeriesDQX · Traditional | 06/13/2013SE |
| K122960 | Steerable Guiding Sheath, Model Adelante DestinoDYB · Traditional | 12/13/2012SE |
| K122958 | Delivery Sheath, Model Adelante BreezewayDYB · Traditional | 12/13/2012SE |
Questions and answers
When was Pacing Lead Adaptors, Bipolar, Models Ilink-Bis, Ilink-Blv cleared by the FDA?
Pacing Lead Adaptors, Bipolar, Models Ilink-Bis, Ilink-Blv (K031164) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on June 19, 2003, 66 days after the submission was received.
What is the product code of K031164?
The FDA product code is DTD – Pacemaker Lead Adaptor, a Class II (moderate risk) device regulated under 21 CFR 870.3620.