Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TRANSDUCER PROTECTOR

K-Number: K912394 · 1991-08-30

ApplicantFiltertek, Inc.
Decision Date1991-08-30
Product CodeFIB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TRANSDUCER PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Filtertek, Inc.. It received FDA 510(k) clearance on 1991-08-30 under 510(k) number K912394. The device is classified under product code FIB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSDUCER PROTECTOR?

TRANSDUCER PROTECTOR is a medical device that received FDA 510(k) clearance on 1991-08-30. The listed applicant is Filtertek, Inc.. The 510(k) number is K912394.

When did TRANSDUCER PROTECTOR receive FDA 510(k) clearance?

TRANSDUCER PROTECTOR received FDA 510(k) clearance on 1991-08-30, under 510(k) number K912394.

Who is the listed applicant for TRANSDUCER PROTECTOR?

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

What is the FDA product code for TRANSDUCER PROTECTOR?

The FDA product code for TRANSDUCER PROTECTOR is FIB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Filtertek, 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.

K981548NFC NEEDLEFREE CONNECTOR MODEL 69900K981547NFC NEEDLEFREE Y-SITE, MODEL 69970K914792PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SETK912848I.V. FILTER EXTENSION SETK911451I.V. EXTENDER SETK904912TRANSDUCER PROTECTOR

View all 10 devices →

Related Devices (Code: FIB)

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.

K240164NovaLine SP-C35 Transducer Protector (956007)Bain Medical Equipment (Guangzhou) Co., Ltd.K072988NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1Nipro Medical CorporationK001971HEMODIALYSIS TUBING SETSOfi Biomedica S.P.A.K010264NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SETNipro Medical Corp.K001465NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SETNipro Medical Corp.K003445FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2Fresenius Medical Care North America

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.

↑