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)

MICROTHIN-PII BIPOLAR PULSE GEN. #0621

K-Number: K803035 · 1980-12-22

ApplicantCardiac Pacemakers, Inc.
Decision Date1980-12-22
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MICROTHIN-PII BIPOLAR PULSE GEN. #0621 is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Pacemakers, Inc.. It received FDA 510(k) clearance on 1980-12-22 under 510(k) number K803035. 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 MICROTHIN-PII BIPOLAR PULSE GEN. #0621?

MICROTHIN-PII BIPOLAR PULSE GEN. #0621 is a medical device that received FDA 510(k) clearance on 1980-12-22. The listed applicant is Cardiac Pacemakers, Inc.. The 510(k) number is K803035.

When did MICROTHIN-PII BIPOLAR PULSE GEN. #0621 receive FDA 510(k) clearance?

MICROTHIN-PII BIPOLAR PULSE GEN. #0621 received FDA 510(k) clearance on 1980-12-22, under 510(k) number K803035.

Who is the listed applicant for MICROTHIN-PII BIPOLAR PULSE GEN. #0621?

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

What is the FDA product code for MICROTHIN-PII BIPOLAR PULSE GEN. #0621?

The FDA product code for MICROTHIN-PII BIPOLAR PULSE GEN. #0621 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 Cardiac Pacemakers, Inc. 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.

K093969ACUITY BREAK-AWAY GUIDE CATHETERK080154ACUITY UNIVERSAL CUTTERK934727REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELERK920601ASTRA T2, ASTRA T4, ASTRA T6K912379PDT CARRYALL TRANSMITTER, VARIOUS MODELSK905674LEAD STYLET

View all 76 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.

↑