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FDA 510(k)

VICOR PACER, MODEL 410A

K-Number: K880432 · 1988-02-22

ApplicantTpl-Cordis, Inc.
Decision Date1988-02-22
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VICOR PACER, MODEL 410A is the device name listed in this FDA 510(k) record. The listed applicant is Tpl-Cordis, Inc.. It received FDA 510(k) clearance on 1988-02-22 under 510(k) number K880432. 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 VICOR PACER, MODEL 410A?

VICOR PACER, MODEL 410A is a medical device that received FDA 510(k) clearance on 1988-02-22. The listed applicant is Tpl-Cordis, Inc.. The 510(k) number is K880432.

When did VICOR PACER, MODEL 410A receive FDA 510(k) clearance?

VICOR PACER, MODEL 410A received FDA 510(k) clearance on 1988-02-22, under 510(k) number K880432.

Who is the listed applicant for VICOR PACER, MODEL 410A?

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

What is the FDA product code for VICOR PACER, MODEL 410A?

The FDA product code for VICOR PACER, MODEL 410A is DXY. This falls under the Clinical Chemistry category.

Related Clinical Trials

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.

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Other records listing Tpl-Cordis, Inc. 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.

K885240MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEADK882429MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004K880898MULTICOR AND PACEMAKERSK873158MODIFIED MULTICOR AND OMNI-STANICOR PACEMAKERSK873202VICOR, MODEL 410A

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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