Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER

K-Number: K923026 · 1993-08-19

ApplicantBiotronik, GmbH & Co.
Decision Date1993-08-19
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER 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 1993-08-19 under 510(k) number K923026. 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 PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER?

PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER is a medical device that received FDA 510(k) clearance on 1993-08-19. The listed applicant is Biotronik, GmbH & Co.. The 510(k) number is K923026.

When did PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER receive FDA 510(k) clearance?

PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER received FDA 510(k) clearance on 1993-08-19, under 510(k) number K923026.

Who is the listed applicant for PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER?

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 PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER?

The FDA product code for PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER is DXY. This falls under the Clinical Chemistry category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Biotronik, GmbH & Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K000763PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051K923406BIOSCOPEK922742HPM 40 HEART PACEMAKER MONITORK914109PIKOS 01 & PIKOS E 01K910609PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIPK911142LEAD TERMINAL PIN CAPS, VARIOUS MODELS

View all 18 devices →

Related Devices (Code: DXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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 VascularK954092ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)Medtronic VascularK953417MINIFLEX 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.

↑