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)

TRACH CARE SET WITH MICROBAN

K-Number: K964369 · 1997-02-11

ApplicantBallard Medical Products
Decision Date1997-02-11
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRACH CARE SET WITH MICROBAN is the device name listed in this FDA 510(k) record. The listed applicant is Ballard Medical Products. It received FDA 510(k) clearance on 1997-02-11 under 510(k) number K964369. The device is classified under product code BSY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACH CARE SET WITH MICROBAN?

TRACH CARE SET WITH MICROBAN is a medical device that received FDA 510(k) clearance on 1997-02-11. The listed applicant is Ballard Medical Products. The 510(k) number is K964369.

When did TRACH CARE SET WITH MICROBAN receive FDA 510(k) clearance?

TRACH CARE SET WITH MICROBAN received FDA 510(k) clearance on 1997-02-11, under 510(k) number K964369.

Who is the listed applicant for TRACH CARE SET WITH MICROBAN?

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

What is the FDA product code for TRACH CARE SET WITH MICROBAN?

The FDA product code for TRACH CARE SET WITH MICROBAN is BSY.

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 Ballard Medical Products 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.

K030721QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLEK022398REUSABLE BRONCHIAL BIOPSY FORCEPSK013892LUTZ NEEDLEK000495BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLESK993138BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KITK990376BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME

View all 26 devices →

Related Devices (Code: BSY)

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.

K031997MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEMMallinckrodt Dar S.R.L.K992902AMBU HAND POWER SUCTION PUMPAmbu, Inc.K982945DUAL PURPOSE CLOSED CATHETERSpirit Medical Systems, Inc.K981910SUCTION CATHETERNi-Med, Inc.K972258HI-CARE CLOSED SUCTION SYSTEMMallinckrodt MedicalK973199AMSINO SUCTION CATHETERAmsino Intl., 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.

↑