FDA 510(k)

PIKOS LP 01, PIKOS LP E01

K-Number: K945627 · 1996-03-04

Decision Date1996-03-04

Product CodeDXY

Advisory CommitteeCV

DecisionUnknown

Device Summary

PIKOS LP 01, PIKOS LP E01 is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 1996-03-04 under 510(k) number K945627. 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: Unknown.

Frequently Asked Questions

What is the PIKOS LP 01, PIKOS LP E01?

PIKOS LP 01, PIKOS LP E01 is a medical device that received FDA 510(k) clearance on 1996-03-04. The listed applicant is Biotronik, Inc.. The 510(k) number is K945627.

When did PIKOS LP 01, PIKOS LP E01 receive FDA 510(k) clearance?

PIKOS LP 01, PIKOS LP E01 received FDA 510(k) clearance on 1996-03-04, under 510(k) number K945627.

Who is the listed applicant for PIKOS LP 01, PIKOS LP E01?

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

What is the FDA product code for PIKOS LP 01, PIKOS LP E01?

The FDA product code for PIKOS LP 01, PIKOS LP E01 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.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.K952328NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01Biotronik, Inc.

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.