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FDA 510(k)

PACEMAKER, OVALITH-D CARDIAC

K-Number: K790566 · 1979-03-19

ApplicantCaratomic
Decision Date1979-03-19
Product CodeDXY
Advisory CommitteeCV
DecisionUnknown

Device Summary

PACEMAKER, OVALITH-D CARDIAC is the device name listed in this FDA 510(k) record. The listed applicant is Caratomic. It received FDA 510(k) clearance on 1979-03-19 under 510(k) number K790566. 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: Unknown.

Frequently Asked Questions

What is the PACEMAKER, OVALITH-D CARDIAC?

PACEMAKER, OVALITH-D CARDIAC is a medical device that received FDA 510(k) clearance on 1979-03-19. The listed applicant is Caratomic. The 510(k) number is K790566.

When did PACEMAKER, OVALITH-D CARDIAC receive FDA 510(k) clearance?

PACEMAKER, OVALITH-D CARDIAC received FDA 510(k) clearance on 1979-03-19, under 510(k) number K790566.

Who is the listed applicant for PACEMAKER, OVALITH-D CARDIAC?

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

What is the FDA product code for PACEMAKER, OVALITH-D CARDIAC?

The FDA product code for PACEMAKER, OVALITH-D CARDIAC is DXY. This falls under the Clinical Chemistry category.

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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

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

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