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)

CATHETER DRESSING CHANCE SET

K-Number: K771712 · 1977-10-13

ApplicantShield Laboratories, Inc.
Decision Date1977-10-13
Product CodeFRL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CATHETER DRESSING CHANCE SET is the device name listed in this FDA 510(k) record. The listed applicant is Shield Laboratories, Inc.. It received FDA 510(k) clearance on 1977-10-13 under 510(k) number K771712. The device is classified under product code FRL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATHETER DRESSING CHANCE SET?

CATHETER DRESSING CHANCE SET is a medical device that received FDA 510(k) clearance on 1977-10-13. The listed applicant is Shield Laboratories, Inc.. The 510(k) number is K771712.

When did CATHETER DRESSING CHANCE SET receive FDA 510(k) clearance?

CATHETER DRESSING CHANCE SET received FDA 510(k) clearance on 1977-10-13, under 510(k) number K771712.

Who is the listed applicant for CATHETER DRESSING CHANCE SET?

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

What is the FDA product code for CATHETER DRESSING CHANCE SET?

The FDA product code for CATHETER DRESSING CHANCE SET is FRL.

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 Shield Laboratories, 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.

K780735URINARY CATHETER CARE SET

Related Devices (Code: FRL)

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.

K121898STAY FRESH SKIN FOLD MANAGEMENT TEXTILEQuick-Med Technologies, Inc.K110715INTERDRY SILVERMilliken Healthcare Products, LLCK061615INTERDRY TEXTILE WITH SILVERMilliken ChemicalK931626CARAPACE STERILE COTTON BALLSCarapace, Inc.K914081ICAN COTTON RAYON BALLSIcn Pharmaceuticals, Inc.K811990TRACH CLEANING TRAYAssociated 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.

↑