FDA 510(k)

PROGRAMMABLE BIPOLAR CARDIAC GENERATOR

K-Number: K800837 · 1980-06-30

Decision Date1980-06-30

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PROGRAMMABLE BIPOLAR CARDIAC GENERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Arco Medical Products Co.. It received FDA 510(k) clearance on 1980-06-30 under 510(k) number K800837. 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 PROGRAMMABLE BIPOLAR CARDIAC GENERATOR?

PROGRAMMABLE BIPOLAR CARDIAC GENERATOR is a medical device that received FDA 510(k) clearance on 1980-06-30. The listed applicant is Arco Medical Products Co.. The 510(k) number is K800837.

When did PROGRAMMABLE BIPOLAR CARDIAC GENERATOR receive FDA 510(k) clearance?

PROGRAMMABLE BIPOLAR CARDIAC GENERATOR received FDA 510(k) clearance on 1980-06-30, under 510(k) number K800837.

Who is the listed applicant for PROGRAMMABLE BIPOLAR CARDIAC GENERATOR?

The FDA 510(k) record lists Arco Medical Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROGRAMMABLE BIPOLAR CARDIAC GENERATOR?

The FDA product code for PROGRAMMABLE BIPOLAR CARDIAC GENERATOR is DXY. This falls under the Clinical Chemistry category.

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Other records listing Arco Medical Products Co. as applicant

K802588MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN.K801806EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE K801241UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN.K800838ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN.K800326ARCOLITH 3021-CARDIAC PULSE GENERATOR K792216ARCOLITH 2100-CARDIAC PULSE GENERATOR

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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

View on FDA Database →

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