Miscellaneous Pacing Lead
FDA 510(k) K925168 · Oscor Medical Corp.
510(k) numberK925168
Submission
- Device name
- Miscellaneous Pacing Lead
- Applicant
- Oscor Medical Corp.
Palm Harbor, FL, US - Received
- October 13, 1992
- Decision date
- May 3, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K964107 | Oscor Permanent Retractable Screw-In Pacing Lead Model PRDTB · Traditional | 04/01/1997PT |
| K923621 | External Demand PacemakerDTE · Traditional | 05/19/1993SE |
| K912867 | Oscor Medical Corp Permanent Pacing LeadDTB · Traditional | 02/04/1992SE |
| K915008 | Permanent Pacing Pad, ModificationDTB · Traditional | 01/27/1992SE |
| K915007 | Permanent Pacing Leads, ModificationDTB · Traditional | 01/27/1992SE |
| K913393 | Implant Pacing Lead, Retractable, ModificationDTB · Traditional | 09/23/1991SE |
| K913205 | Oscor Medical Fix Screw Pac Lead/Peel Cath, ModifDTB · Traditional | 09/23/1991SE |
| K913204 | Model Ky Pacemaker Lead-Various, ModificationDTB · Traditional | 09/23/1991SE |
| K913203 | Implant Pacing Lead Tined #3390, ModificationDTB · Traditional | 09/23/1991SE |
| K913202 | Implant Pacing Lead, Tined #3262, ModificationDTB · Traditional | 09/23/1991SE |
Questions and answers
When was Miscellaneous Pacing Lead cleared by the FDA?
Miscellaneous Pacing Lead (K925168) received a 510(k) decision of Substantially Equivalent on May 3, 1994, 567 days after the submission was received.
What is the product code of K925168?
The FDA product code is DTD – Pacemaker Lead Adaptor, a Class II (moderate risk) device regulated under 21 CFR 870.3620.