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FDA 510(k)

VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)

K-Number: K890350 · 1989-02-02

ApplicantTelectronics, Inc.
Decision Date1989-02-02
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE) is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics, Inc.. It received FDA 510(k) clearance on 1989-02-02 under 510(k) number K890350. 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 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)?

VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE) is a medical device that received FDA 510(k) clearance on 1989-02-02. The listed applicant is Telectronics, Inc.. The 510(k) number is K890350.

When did VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE) receive FDA 510(k) clearance?

VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE) received FDA 510(k) clearance on 1989-02-02, under 510(k) number K890350.

Who is the listed applicant for VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)?

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

What is the FDA product code for VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)?

The FDA product code for VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE) is DTB.

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Other records listing Telectronics, 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.

K890895IMPLANTABLE ADAPTOR 033-380K891231OPTIMA MPT AND SPT PACEMAKERSK884411OPTIMA MPT AND SPT PACEMAKERSK884278IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436K881837OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282DK874664IMPLANTABLE ELECTRODE LEAD, MODEL 030-446

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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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