FDA 510(k)

LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD

K-Number: K894494 · 1989-10-17

Decision Date1989-10-17

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, GmbH & Co.. It received FDA 510(k) clearance on 1989-10-17 under 510(k) number K894494. 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 LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD?

LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD is a medical device that received FDA 510(k) clearance on 1989-10-17. The listed applicant is Biotronik, GmbH & Co.. The 510(k) number is K894494.

When did LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD receive FDA 510(k) clearance?

LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD received FDA 510(k) clearance on 1989-10-17, under 510(k) number K894494.

Who is the listed applicant for LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD?

The FDA 510(k) record lists Biotronik, GmbH & Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD?

The FDA product code for LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD is DXY. This falls under the Clinical Chemistry category.

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Other records listing Biotronik, GmbH & Co. as applicant

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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.