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FDA 510(k)

MODEL 5866-9M & MODEL 6981M

K-Number: K911827 · 1991-07-23

ApplicantMetronic, Inc.
Decision Date1991-07-23
Product CodeDTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 5866-9M & MODEL 6981M is the device name listed in this FDA 510(k) record. The listed applicant is Metronic, Inc.. It received FDA 510(k) clearance on 1991-07-23 under 510(k) number K911827. The device is classified under product code DTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 5866-9M & MODEL 6981M?

MODEL 5866-9M & MODEL 6981M is a medical device that received FDA 510(k) clearance on 1991-07-23. The listed applicant is Metronic, Inc.. The 510(k) number is K911827.

When did MODEL 5866-9M & MODEL 6981M receive FDA 510(k) clearance?

MODEL 5866-9M & MODEL 6981M received FDA 510(k) clearance on 1991-07-23, under 510(k) number K911827.

Who is the listed applicant for MODEL 5866-9M & MODEL 6981M?

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

What is the FDA product code for MODEL 5866-9M & MODEL 6981M?

The FDA product code for MODEL 5866-9M & MODEL 6981M is DTD.

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 Metronic, 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.

K031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADK874884MEDTRONIC(R) ORTHOFLEX(TM)K832505IMAGE PROCESSING SYS A3

Related Devices (Code: DTD)

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.

K1320086981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAPMedtronic, Inc.K041574CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020Guidant CorporationK031164PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLVOscor, Inc.K024156PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAROscor, Inc.K010787PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONSOscor, Inc.K003454A1-CS-SB Y-ADAPTER, MODEL 124 871Biotronik, 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.

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