FDA 510(k)

PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY

K-Number: K861422 · 1986-06-26

Decision Date1986-06-26

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY is the device name listed in this FDA 510(k) record. The listed applicant is Pacesetter Systems. It received FDA 510(k) clearance on 1986-06-26 under 510(k) number K861422. 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 PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY?

PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY is a medical device that received FDA 510(k) clearance on 1986-06-26. The listed applicant is Pacesetter Systems. The 510(k) number is K861422.

When did PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY receive FDA 510(k) clearance?

PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY received FDA 510(k) clearance on 1986-06-26, under 510(k) number K861422.

Who is the listed applicant for PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY?

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

What is the FDA product code for PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY?

The FDA product code for PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY is DXY. This falls under the Clinical Chemistry category.

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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.