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FDA 510(k)

MAXIM PF MODELS 033-581/033-590

K-Number: K961118 · 1996-07-15

ApplicantTelectronics Pacing Systems, Inc.
Decision Date1996-07-15
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

MAXIM PF MODELS 033-581/033-590 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 1996-07-15 under 510(k) number K961118. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the MAXIM PF MODELS 033-581/033-590?

MAXIM PF MODELS 033-581/033-590 is a medical device that received FDA 510(k) clearance on 1996-07-15. The listed applicant is Telectronics Pacing Systems, Inc.. The 510(k) number is K961118.

When did MAXIM PF MODELS 033-581/033-590 receive FDA 510(k) clearance?

MAXIM PF MODELS 033-581/033-590 received FDA 510(k) clearance on 1996-07-15, under 510(k) number K961118.

Who is the listed applicant for MAXIM PF MODELS 033-581/033-590?

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 MAXIM PF MODELS 033-581/033-590?

The FDA product code for MAXIM PF MODELS 033-581/033-590 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.

K943657STERILIZATIONK934899BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MMK926340NEW LEAD INTRODUCER KITS, VARIOUS MODELSK914489NEW EXTRUSION VENDOR FOR POLYURETHANE TUBINGK913919UNIVERSAL TERMINAL CAP, 3.2MMK912773UNIPOLAR UPSIZING ADAPTOR

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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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