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)

MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE

K-Number: K812305 · 1981-09-08

ApplicantBoston Medical Products, Inc.
Decision Date1981-09-08
Product CodeKCF
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Boston Medical Products, Inc.. It received FDA 510(k) clearance on 1981-09-08 under 510(k) number K812305. The device is classified under product code KCF. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE?

MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE is a medical device that received FDA 510(k) clearance on 1981-09-08. The listed applicant is Boston Medical Products, Inc.. The 510(k) number is K812305.

When did MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE receive FDA 510(k) clearance?

MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE received FDA 510(k) clearance on 1981-09-08, under 510(k) number K812305.

Who is the listed applicant for MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE?

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

What is the FDA product code for MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE?

The FDA product code for MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE is KCF.

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 Boston Medical Products, 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.

K091135RUTTER SUPRA STOMAL STENTSK972317MONTGOMERY THYROPLASTY IMPLANT SYSTEMK972459RHINOCELL NASAL PACKINGSK972096BIVALVE NASAL SPLINTK972078POST-STOP EPISTAXIS CATHETERK972092NASAL AIRWAY SPLINT

View all 33 devices →

Related Devices (Code: KCF)

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.

K962688MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBEBoston Medical Products, Inc.K923355PHARYNGEAL SALIVARY BYPASS TUBEBoston Medical Products, 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.

↑