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FDA 510(k)

PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR

K-Number: K870142 · 1987-04-22

ApplicantCardio-Pace Medical, Inc.
Decision Date1987-04-22
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR is the device name listed in this FDA 510(k) record. The listed applicant is Cardio-Pace Medical, Inc.. It received FDA 510(k) clearance on 1987-04-22 under 510(k) number K870142. 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 PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR?

PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR is a medical device that received FDA 510(k) clearance on 1987-04-22. The listed applicant is Cardio-Pace Medical, Inc.. The 510(k) number is K870142.

When did PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR receive FDA 510(k) clearance?

PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR received FDA 510(k) clearance on 1987-04-22, under 510(k) number K870142.

Who is the listed applicant for PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR?

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

What is the FDA product code for PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR?

The FDA product code for PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR 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 Cardio-Pace Medical, 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.

K853771PINNACLE MULTI-PROGRAMMABLE PACING SYSK853425CARIO-PACE DURAPULSE P101 COATED PULSE GENERATOR

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

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

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