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FDA 510(k)

ADAPTING SLEEVE KIT MODEL 4023

K-Number: K921318 · 1992-08-03

ApplicantSiemens-Pacesetter, Inc.
Decision Date1992-08-03
Product CodeDTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ADAPTING SLEEVE KIT MODEL 4023 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens-Pacesetter, Inc.. It received FDA 510(k) clearance on 1992-08-03 under 510(k) number K921318. 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 ADAPTING SLEEVE KIT MODEL 4023?

ADAPTING SLEEVE KIT MODEL 4023 is a medical device that received FDA 510(k) clearance on 1992-08-03. The listed applicant is Siemens-Pacesetter, Inc.. The 510(k) number is K921318.

When did ADAPTING SLEEVE KIT MODEL 4023 receive FDA 510(k) clearance?

ADAPTING SLEEVE KIT MODEL 4023 received FDA 510(k) clearance on 1992-08-03, under 510(k) number K921318.

Who is the listed applicant for ADAPTING SLEEVE KIT MODEL 4023?

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

What is the FDA product code for ADAPTING SLEEVE KIT MODEL 4023?

The FDA product code for ADAPTING SLEEVE KIT MODEL 4023 is DTD.

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Other records listing Siemens-Pacesetter, 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.

K942440AFP CARDIAC PACING SYSTEM MODEL 283K925038PACING LEAD MODEL 1188TK932892PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELSK930876SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146TK925347MODEL 1148T TRANSVENOUS, SCREW-IN LEADK920822CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE

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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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