FDA 510(k)

MEDTRONIC MINIX & MINIX ST PULSE GENERATORS

K-Number: K930770 · 1993-05-14

Decision Date1993-05-14

Product CodeDXY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MEDTRONIC MINIX & MINIX ST PULSE GENERATORS is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1993-05-14 under 510(k) number K930770. 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 MEDTRONIC MINIX & MINIX ST PULSE GENERATORS?

MEDTRONIC MINIX & MINIX ST PULSE GENERATORS is a medical device that received FDA 510(k) clearance on 1993-05-14. The listed applicant is Medtronic Vascular. The 510(k) number is K930770.

When did MEDTRONIC MINIX & MINIX ST PULSE GENERATORS receive FDA 510(k) clearance?

MEDTRONIC MINIX & MINIX ST PULSE GENERATORS received FDA 510(k) clearance on 1993-05-14, under 510(k) number K930770.

Who is the listed applicant for MEDTRONIC MINIX & MINIX ST PULSE GENERATORS?

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 MEDTRONIC MINIX & MINIX ST PULSE GENERATORS?

The FDA product code for MEDTRONIC MINIX & MINIX ST PULSE GENERATORS is DXY. This falls under the Clinical Chemistry category.

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Other records listing Medtronic Vascular 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

View on FDA Database →

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