FDA 510(k)

BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS

K-Number: K854143 · 1985-11-01

Decision Date1985-11-01

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics, Inc.. It received FDA 510(k) clearance on 1985-11-01 under 510(k) number K854143. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS?

BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS is a medical device that received FDA 510(k) clearance on 1985-11-01. The listed applicant is Telectronics, Inc.. The 510(k) number is K854143.

When did BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS receive FDA 510(k) clearance?

BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS received FDA 510(k) clearance on 1985-11-01, under 510(k) number K854143.

Who is the listed applicant for BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS?

The FDA 510(k) record lists Telectronics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS?

The FDA product code for BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS is DXY. This falls under the Clinical Chemistry category.

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Other records listing Telectronics, Inc. as applicant

K890895IMPLANTABLE ADAPTOR 033-380 K891231OPTIMA MPT AND SPT PACEMAKERS K890350VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)K884411OPTIMA MPT AND SPT PACEMAKERS K884278IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436 K881837OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D

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Related Devices (Code: DXY)

K993434PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-ABiotronik, Inc.K970072OPUS S MODEL 4121 AND 4124 PACEMAKERSEla Medical, Inc.K945627PIKOS LP 01, PIKOS LP E01Biotronik, Inc.K953866MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)Medtronic Vascular K954092ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)Medtronic Vascular K953417MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORSCook Pacemaker Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.