Pikos LP 01, Pikos LP E01

FDA 510(k) K945627 · Biotronik, Inc.

Unknown

510(k) numberK945627

Submission

Device name
Pikos LP 01, Pikos LP E01
Applicant
Biotronik, Inc.
Lake Oswego, OR, US
Received
November 16, 1994
Decision date
March 4, 1996
Decision
Unknown (SESP)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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
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
K946188CCDS Maestro(R) II Series 200 Cadiac PacemakerDXY · Traditional Cardiac Control Systems, Inc.05/15/1995ST

More from Cardiac Control Systems, Inc.

510(k)DeviceDecision
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K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters…LIT · Special 04/04/2025SE
K242969Pantera Pro; Pantera LEOLOX · Special 10/25/2024SE
K240787Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool…DQY · Traditional 09/12/2024SE
K241711Oscar Peripheral Multifunctional Catheter systemLIT · Special 07/11/2024SE
K230375Biomonitor IVMXD · Traditional 05/19/2023SE
K222065Passeo-35 Xeo Peripheral Dilatation CatheterLIT · Traditional 02/16/2023SE
K221856BIOMONITOR IIIm, BIOMONITOR IIIMXD · Special 07/27/2022SE
K222037Selectra Lead Implantation SystemDQY · Special 07/19/2022SE
K214038Oscar Peripheral Multifunctional Catheter systemLIT · Traditional 07/06/2022SE

Questions and answers

When was Pikos LP 01, Pikos LP E01 cleared by the FDA?

Pikos LP 01, Pikos LP E01 (K945627) received a 510(k) decision of Unknown on March 4, 1996, 474 days after the submission was received.

What is the product code of K945627?

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