FDA 510(k)

CERYX PACEMAKER MODELS 114, 314 & 614

K-Number: K854790 · 1986-08-28

Decision Date1986-08-28

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CERYX PACEMAKER MODELS 114, 314 & 614 is the device name listed in this FDA 510(k) record. The listed applicant is Vitatron Medical BV. It received FDA 510(k) clearance on 1986-08-28 under 510(k) number K854790. 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 CERYX PACEMAKER MODELS 114, 314 & 614?

CERYX PACEMAKER MODELS 114, 314 & 614 is a medical device that received FDA 510(k) clearance on 1986-08-28. The listed applicant is Vitatron Medical BV. The 510(k) number is K854790.

When did CERYX PACEMAKER MODELS 114, 314 & 614 receive FDA 510(k) clearance?

CERYX PACEMAKER MODELS 114, 314 & 614 received FDA 510(k) clearance on 1986-08-28, under 510(k) number K854790.

Who is the listed applicant for CERYX PACEMAKER MODELS 114, 314 & 614?

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

What is the FDA product code for CERYX PACEMAKER MODELS 114, 314 & 614?

The FDA product code for CERYX PACEMAKER MODELS 114, 314 & 614 is DXY. This falls under the Clinical Chemistry category.

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Other records listing Vitatron Medical BV as applicant

K844484HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA K844483TP 1 K844485CERYX6, 611, CERYX 3 311 & CERYX 1 111 K840668ELECTRODE PACEMAKER, PERM & TEMP K831859PACEMAKER PROGRAMMER #2032 K831860GENERATOR, PULSE, PACEMAKER #532

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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.