Sterile Packaging

FDA 510(k) K810410 · Telectronics, Inc.

Substantially Equivalent

510(k) numberK810410

Submission

Device name
Sterile Packaging
Applicant
Telectronics, Inc.
Mchenry, IL, US
Received
February 18, 1981
Decision date
March 5, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DXY – Implantable Pacemaker Pulse-Generator
Device class
Class III (high risk)
Regulation
21 CFR 870.3610
Specialty
Cardiovascular
Implant
Yes

Other 510(k)s with product code DXY

510(k)DeviceApplicantDecision
K993434Pikos 01, Pikos E01, Pikos 01-B, Pikos E01-B, Pikos 01-A, Pikos E01-ADXY · Special Biotronik, Inc.11/10/1999SE
K970072Opus S Model 4121 and 4124 PacemakersDXY · Traditional Ela Medical, Inc.08/29/1997ST
K945627Pikos LP 01, Pikos LP E01DXY · Traditional Biotronik, Inc.03/04/1996SESP
K954092Alternate Sterlization Process & Modified DF-1 Lead Connector (Modification)DXY · Traditional Medtronic Vascular12/15/1995ST
K953866Minix 834M & Minix ST 8331M Pulse Generators (Modification)DXY · Traditional Medtronic Vascular12/15/1995ST
K953417Miniflex Model 340, 341, and 342 Pulse GeneratorsDXY · Traditional Cook Pacemaker Corp.09/29/1995ST
K952328Nanos, Pikos 01/E01, 01-A, E01-B, LP 01/LP E01DXY · Traditional Biotronik, Inc.09/29/1995ST
K952364Opus Pacemakers (Models 4001, 4003, 4004, 4023, 4024)DXY · Traditional Ela Medical, Inc.09/01/1995ST
K940039Pellethane 75DDXY · Traditional Medtronic Vascular07/12/1995ST
K950751Tecothane 75D Polyurethane Resin for Pulse Generator Connector ModulesDXY · Traditional Medtronic Vascular05/15/1995ST

More from Medtronic Vascular

510(k)DeviceDecision
K890895Implantable Adaptor 033-380DTD · Traditional 03/06/1990SE
K891231Optima MPT and SPT PacemakersDXY · Traditional 09/12/1989SE
K890350VS-1 Silicone Implant Leads (New Serial # Tube)DTB · Traditional 02/02/1989SE
K884411Optima MPT and SPT PacemakersDXY · Traditional 01/26/1989SE
K884278Implantable Electrode Leads 033-400,402 and 436DTB · Traditional 12/15/1988SE
K881837Optima MPT Series III Pacemaker, 5281D and 5282DDXY · Traditional 07/18/1988SE
K874664Implantable Electrode Lead, Model 030-446DTB · Traditional 05/31/1988SE
K864712Model 1740 Personal Pocket ProgrammerKRG · Traditional 12/17/1987SE
K872766Implantable Programmable Cardiac Pulse GeneratorsDXY · Traditional 11/04/1987SE
K865098Slimline Unipolar Endocardial Pacing Lead, 030-438DTB · Traditional 08/18/1987SE

Questions and answers

When was Sterile Packaging cleared by the FDA?

Sterile Packaging (K810410) received a 510(k) decision of Substantially Equivalent on March 5, 1981, 15 days after the submission was received.

What is the product code of K810410?

The FDA product code is DXY – Implantable Pacemaker Pulse-Generator, a Class III (high risk) device regulated under 21 CFR 870.3610.