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FDA 510(k)

BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM

K-Number: K934899 · 1994-05-12

ApplicantTelectronics Pacing Systems, Inc.
Decision Date1994-05-12
Product CodeDTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics Pacing Systems, Inc.. It received FDA 510(k) clearance on 1994-05-12 under 510(k) number K934899. 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 BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM?

BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM is a medical device that received FDA 510(k) clearance on 1994-05-12. The listed applicant is Telectronics Pacing Systems, Inc.. The 510(k) number is K934899.

When did BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM receive FDA 510(k) clearance?

BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM received FDA 510(k) clearance on 1994-05-12, under 510(k) number K934899.

Who is the listed applicant for BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM?

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

What is the FDA product code for BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM?

The FDA product code for BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM is DTD.

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Other records listing Telectronics Pacing Systems, 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.

K961118MAXIM PF MODELS 033-581/033-590K943657STERILIZATIONK926340NEW LEAD INTRODUCER KITS, VARIOUS MODELSK914489NEW EXTRUSION VENDOR FOR POLYURETHANE TUBINGK913919UNIVERSAL TERMINAL CAP, 3.2MMK912773UNIPOLAR UPSIZING ADAPTOR

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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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