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)

SURELOC CIRCUIT CONNECTOR

K-Number: K954383 · 1995-12-22

ApplicantPolamedco, Inc.
Decision Date1995-12-22
Product CodeBZA
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SURELOC CIRCUIT CONNECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Polamedco, Inc.. It received FDA 510(k) clearance on 1995-12-22 under 510(k) number K954383. The device is classified under product code BZA. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURELOC CIRCUIT CONNECTOR?

SURELOC CIRCUIT CONNECTOR is a medical device that received FDA 510(k) clearance on 1995-12-22. The listed applicant is Polamedco, Inc.. The 510(k) number is K954383.

When did SURELOC CIRCUIT CONNECTOR receive FDA 510(k) clearance?

SURELOC CIRCUIT CONNECTOR received FDA 510(k) clearance on 1995-12-22, under 510(k) number K954383.

Who is the listed applicant for SURELOC CIRCUIT CONNECTOR?

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

What is the FDA product code for SURELOC CIRCUIT CONNECTOR?

The FDA product code for SURELOC CIRCUIT CONNECTOR is BZA.

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 Polamedco, 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.

K983000CRICOTHYROTOMY TUBEK953793INTROSCOPEK950713AIRGUIDE STYLETTEK933596GASTRIC, CATHETER, IRRIGATION & ASPIRATIONK950380FLEXTITIP STYLETTEK920900POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES

View all 20 devices →

Related Devices (Code: BZA)

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.

K083702TRACH-ASSISTMergenet MedicalK954197DISPOSABLE FLEX TUBEEngstrom MedicalK953786UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONSUnicor, Inc.K952824NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTORIntertex Medical, Inc.K951345DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLINGCatheter Research, Inc.K944532PRIMA, INC. VENTILATOR HOSESPrima, 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.

↑