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FDA 510(k)

ASTRA 2,3,4 AND 6: CHIP REVISION

K-Number: K863000 · 1986-08-19

ApplicantCardiac Pacemakers, Inc.
Decision Date1986-08-19
Product Code
DecisionSubstantially Equivalent

Device Summary

ASTRA 2,3,4 AND 6: CHIP REVISION 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 1986-08-19 under 510(k) number K863000. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASTRA 2,3,4 AND 6: CHIP REVISION?

ASTRA 2,3,4 AND 6: CHIP REVISION is a medical device that received FDA 510(k) clearance on 1986-08-19. The listed applicant is Cardiac Pacemakers, Inc.. The 510(k) number is K863000.

When did ASTRA 2,3,4 AND 6: CHIP REVISION receive FDA 510(k) clearance?

ASTRA 2,3,4 AND 6: CHIP REVISION received FDA 510(k) clearance on 1986-08-19, under 510(k) number K863000.

Who is the listed applicant for ASTRA 2,3,4 AND 6: CHIP REVISION?

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

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

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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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