STERILIZATION — FDA 510(k) K943657

Device Summary

STERILIZATION 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 1996-06-24 under 510(k) number K943657. 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 STERILIZATION?

STERILIZATION is a medical device that received FDA 510(k) clearance on 1996-06-24. The listed applicant is Telectronics Pacing Systems, Inc.. The 510(k) number is K943657.

When did STERILIZATION receive FDA 510(k) clearance?

STERILIZATION received FDA 510(k) clearance on 1996-06-24, under 510(k) number K943657.

Who is the listed applicant for STERILIZATION?

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 STERILIZATION?

The FDA product code for STERILIZATION is DTB.

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Related PubMed Literature

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.

PMID: 34430278Preparation and sterilization of an implantable drug-delivery microdevice for clinical use.MethodsX ()PMID: 35047882Medical Device Sterilization and Reprocessing in the Era of Multidrug-Resistant (MDR) Bacteria: Issues and Regulatory Concepts.Frontiers in medical technology ()PMID: 29602568Evaluation of Ophthalmic Surgical Instrument Sterility Using Short-Cycle Sterilization for Sequential Same-Day Use.Ophthalmology ()

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 033-581/033-590 K934899BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM K926340NEW LEAD INTRODUCER KITS, VARIOUS MODELS K914489NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING K913919UNIVERSAL TERMINAL CAP, 3.2MM K912773UNIPOLAR 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 Vascular K031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.