Adapter Kit

FDA 510(k) K781864 · Daig Corp.

Substantially Equivalent

510(k) numberK781864

Submission

Device name
Adapter Kit
Applicant
Daig Corp.
Walker, MI, US
Received
November 6, 1978
Decision date
December 19, 1978
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

Other 510(k)s with product code DTD

510(k)DeviceApplicantDecision
K143463IS4/DF4 Port PlugDTD · Traditional Oscor, Inc.03/19/2015SE
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

More from Biotronik, Inc.

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K982299Spyglass 5 FR Angiographic CatheterDQO · Traditional 10/19/1998SE
K982187Fast-Cath Intra-Cardiac IntroducerDYB · Traditional 09/16/1998SE
K973840Fast-Cath (TM) Intra-Cardiac IntroducerDYB · Traditional 05/21/1998SE
K964518Fast-Cath Transseptal Catheter IntroducerDYB · Traditional 05/14/1997SE
K965249Spyglass Angiographic CatheterDQO · Traditional 02/21/1997SE
K962805Spyglass Angiographic CatheterDQO · Traditional 10/15/1996SE
K954317Diag Fast-Cath Duo & Trio Removable Hemostasis Adapters W/Sideports & 3-WAY StopcocksDYB · Traditional 11/28/1995SE
K944284ControlDQO · Traditional 03/03/1995SE

Questions and answers

When was Adapter Kit cleared by the FDA?

Adapter Kit (K781864) received a 510(k) decision of Substantially Equivalent on December 19, 1978, 43 days after the submission was received.

What is the product code of K781864?

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