FDA 510(k)

ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN.

K-Number: K862974 · 1986-09-04

Decision Date1986-09-04

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN. is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1986-09-04 under 510(k) number K862974. 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 ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN.?

ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN. is a medical device that received FDA 510(k) clearance on 1986-09-04. The listed applicant is Medtronic Vascular. The 510(k) number is K862974.

When did ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN. receive FDA 510(k) clearance?

ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN. received FDA 510(k) clearance on 1986-09-04, under 510(k) number K862974.

Who is the listed applicant for ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN.?

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

What is the FDA product code for ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN.?

The FDA product code for ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN. 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

View on FDA Database →

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