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FDA 510(k)

ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN.

K-Number: K800838 · 1980-06-04

ApplicantArco Medical Products Co.
Decision Date1980-06-04
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN. 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 1980-06-04 under 510(k) number K800838. 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 ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN.?

ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN. is a medical device that received FDA 510(k) clearance on 1980-06-04. The listed applicant is Arco Medical Products Co.. The 510(k) number is K800838.

When did ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN. receive FDA 510(k) clearance?

ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN. received FDA 510(k) clearance on 1980-06-04, under 510(k) number K800838.

Who is the listed applicant for ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN.?

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 ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN.?

The FDA product code for ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN. is DXY. This falls under the Clinical Chemistry category.

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Other records listing Arco Medical Products Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K802588MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN.K801806EXTERNAL SILASTIC BOOT FOR CARDIAC PULSEK801241UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN.K800837PROGRAMMABLE BIPOLAR CARDIAC GENERATORK800326ARCOLITH 3021-CARDIAC PULSE GENERATORK792216ARCOLITH 2100-CARDIAC PULSE GENERATOR

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Related Devices (Code: DXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 VascularK954092ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)Medtronic VascularK953417MINIFLEX 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.

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