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FDA 510(k)

SENTRA

K-Number: K843060 · 1984-09-20

ApplicantCardiac Pacemakers, Inc.
Decision Date1984-09-20
Product CodeDTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SENTRA 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 1984-09-20 under 510(k) number K843060. 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 SENTRA?

SENTRA is a medical device that received FDA 510(k) clearance on 1984-09-20. The listed applicant is Cardiac Pacemakers, Inc.. The 510(k) number is K843060.

When did SENTRA receive FDA 510(k) clearance?

SENTRA received FDA 510(k) clearance on 1984-09-20, under 510(k) number K843060.

Who is the listed applicant for SENTRA?

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 SENTRA?

The FDA product code for SENTRA is DTD.

Related Clinical Trials

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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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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

View on FDA Database →

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

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