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FDA 510(k)

STYLET INTRODUCER FUNNEL

K-Number: K854142 · 1986-01-15

ApplicantTelectronics, Inc.
Decision Date1986-01-15
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STYLET INTRODUCER FUNNEL is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics, Inc.. It received FDA 510(k) clearance on 1986-01-15 under 510(k) number K854142. 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 STYLET INTRODUCER FUNNEL?

STYLET INTRODUCER FUNNEL is a medical device that received FDA 510(k) clearance on 1986-01-15. The listed applicant is Telectronics, Inc.. The 510(k) number is K854142.

When did STYLET INTRODUCER FUNNEL receive FDA 510(k) clearance?

STYLET INTRODUCER FUNNEL received FDA 510(k) clearance on 1986-01-15, under 510(k) number K854142.

Who is the listed applicant for STYLET INTRODUCER FUNNEL?

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 STYLET INTRODUCER FUNNEL?

The FDA product code for STYLET INTRODUCER FUNNEL 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.

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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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