IS4/DF4 Port Plug

FDA 510(k) K143463 · Oscor, Inc.

Substantially Equivalent

510(k) numberK143463

Submission

Device name
IS4/DF4 Port Plug
Applicant
Oscor, Inc.
Palm Harbor, FL, US
Received
December 4, 2014
Decision date
March 19, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

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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K1320086981M Lead Extender Kit, 6984M Lead Extender Kit, 6986M Lead Extender Kit, 5866-24M Lead…DTD · Special Medtronic, Inc.07/30/2013SE
K041574Cpi Lead Adapters, Models 6017, 6018 and 6020DTD · Special Guidant Corporation07/12/2004SE
K031164Pacing Lead Adaptors, Bipolar, Models Ilink-Bis, Ilink-BlvDTD · Special Oscor, Inc.06/19/2003ST
K024156Pacing Lead Extensions, Bipolar, Pacing Lead Adaptors, Unipolar/Bipolar,Pacing Lead…DTD · Special Oscor, Inc.01/14/2003SE
K010787Pacing Lead Bipolar Adapters and ExtensionsDTD · Traditional Oscor, Inc.05/22/2001SE
K003454A1-CS-SB Y-Adapter, Model 124 871DTD · Special Biotronik, Inc.01/18/2001ST
K000210Modification to Model 5866-37M Lead Adaptor KitDTD · Special Medtronic Vascular02/23/2000ST
K982220Model 2872 Bipolar Lead Adaptor KitDTD · Traditional Medtronic Vascular10/15/1998ST
K971930Bk-N Sealing CapDTD · Traditional Biotronik, Inc.08/14/1997PT
K970388A1-A,ABP,B,MBP, Lead Connectors; Peh Adapter SleeveDTD · Traditional Biotronik, Inc.08/14/1997PT

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Questions and answers

When was IS4/DF4 Port Plug cleared by the FDA?

IS4/DF4 Port Plug (K143463) received a 510(k) decision of Substantially Equivalent on March 19, 2015, 105 days after the submission was received.

What is the product code of K143463?

The FDA product code is DTD – Pacemaker Lead Adaptor, a Class II (moderate risk) device regulated under 21 CFR 870.3620.