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FDA 510(k)

AFP CARDIAC PACING SYSTEM MODEL 283

K-Number: K942440 · 1994-08-08

ApplicantSiemens-Pacesetter, Inc.
Decision Date1994-08-08
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

AFP CARDIAC PACING SYSTEM MODEL 283 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 1994-08-08 under 510(k) number K942440. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the AFP CARDIAC PACING SYSTEM MODEL 283?

AFP CARDIAC PACING SYSTEM MODEL 283 is a medical device that received FDA 510(k) clearance on 1994-08-08. The listed applicant is Siemens-Pacesetter, Inc.. The 510(k) number is K942440.

When did AFP CARDIAC PACING SYSTEM MODEL 283 receive FDA 510(k) clearance?

AFP CARDIAC PACING SYSTEM MODEL 283 received FDA 510(k) clearance on 1994-08-08, under 510(k) number K942440.

Who is the listed applicant for AFP CARDIAC PACING SYSTEM MODEL 283?

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 AFP CARDIAC PACING SYSTEM MODEL 283?

The FDA product code for AFP CARDIAC PACING SYSTEM MODEL 283 is DTB.

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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.

K925038PACING LEAD MODEL 1188TK932892PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELSK930876SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146TK925347MODEL 1148T TRANSVENOUS, SCREW-IN LEADK920822CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODEK921318ADAPTING SLEEVE KIT MODEL 4023

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Related Devices (Code: DTB)

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.

K061212BIOTRONIK ENDOCARDIAL PACING LEADSBiotronik, Inc.K041809PERMANENT PACING LEAD, MODEL PY2Oscor, Inc.K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUOscor, Inc.K031274MODEL 5071 MYOCARDIAL PACING LEADMedtronic VascularK031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, 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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