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FDA 510(k)

STERILE TRACHEOSTOMY CARE KIT

K-Number: K821501 · 1982-06-16

ApplicantPro-Pak
Decision Date1982-06-16
Product CodeKDD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE TRACHEOSTOMY CARE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Pro-Pak. It received FDA 510(k) clearance on 1982-06-16 under 510(k) number K821501. The device is classified under product code KDD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE TRACHEOSTOMY CARE KIT?

STERILE TRACHEOSTOMY CARE KIT is a medical device that received FDA 510(k) clearance on 1982-06-16. The listed applicant is Pro-Pak. The 510(k) number is K821501.

When did STERILE TRACHEOSTOMY CARE KIT receive FDA 510(k) clearance?

STERILE TRACHEOSTOMY CARE KIT received FDA 510(k) clearance on 1982-06-16, under 510(k) number K821501.

Who is the listed applicant for STERILE TRACHEOSTOMY CARE KIT?

The FDA 510(k) record lists Pro-Pak as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE TRACHEOSTOMY CARE KIT?

The FDA product code for STERILE TRACHEOSTOMY CARE KIT is KDD.

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 Pro-Pak 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.

K821502STERILE SUTURE REMOVAL KITK821500STERILE CATH CARE KIT

Related Devices (Code: KDD)

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.

K072814CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURESCovidienK011514INSTRUMENTS FOR ONE TIME USE - DISPOSABLEKencap , Ltd.K971317NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYSNational Healthcare Mfg. Corp.K960456DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAYDenver Biomaterials, Inc.K936255CUSTOM CV PACKAssociated MedicalK932219SUTURE SET OR LACERATION TRAYS (PACKS)Associated Medical Products Co.

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.

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