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FDA 510(k)

VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458

K-Number: K901402 · 1990-06-12

ApplicantTelectronics Pacing Systems, Inc.
Decision Date1990-06-12
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458 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 1990-06-12 under 510(k) number K901402. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458?

VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458 is a medical device that received FDA 510(k) clearance on 1990-06-12. The listed applicant is Telectronics Pacing Systems, Inc.. The 510(k) number is K901402.

When did VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458 receive FDA 510(k) clearance?

VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458 received FDA 510(k) clearance on 1990-06-12, under 510(k) number K901402.

Who is the listed applicant for VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458?

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 VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458?

The FDA product code for VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458 is DTB.

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 033-581/033-590K943657STERILIZATIONK934899BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MMK926340NEW LEAD INTRODUCER KITS, VARIOUS MODELSK914489NEW EXTRUSION VENDOR FOR POLYURETHANE TUBINGK913919UNIVERSAL TERMINAL CAP, 3.2MM

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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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