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FDA 510(k)

NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI

K-Number: K893041 · 1989-11-14

ApplicantTelectronics Pacing Systems, Inc.
Decision Date1989-11-14
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI 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 1989-11-14 under 510(k) number K893041. 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 NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI?

NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI is a medical device that received FDA 510(k) clearance on 1989-11-14. The listed applicant is Telectronics Pacing Systems, Inc.. The 510(k) number is K893041.

When did NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI receive FDA 510(k) clearance?

NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI received FDA 510(k) clearance on 1989-11-14, under 510(k) number K893041.

Who is the listed applicant for NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI?

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 NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI?

The FDA product code for NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI is DTB.

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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 033-581/033-590K943657STERILIZATIONK934899BIFURCATED 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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