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FDA 510(k)

INTRAVENOUS CATHETERS MODIFICATIONS

K-Number: K921295 · 1993-05-17

ApplicantCritikon Company, LLC
Decision Date1993-05-17
Product CodeFGO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INTRAVENOUS CATHETERS MODIFICATIONS is the device name listed in this FDA 510(k) record. The listed applicant is Critikon Company, LLC. It received FDA 510(k) clearance on 1993-05-17 under 510(k) number K921295. The device is classified under product code FGO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRAVENOUS CATHETERS MODIFICATIONS?

INTRAVENOUS CATHETERS MODIFICATIONS is a medical device that received FDA 510(k) clearance on 1993-05-17. The listed applicant is Critikon Company, LLC. The 510(k) number is K921295.

When did INTRAVENOUS CATHETERS MODIFICATIONS receive FDA 510(k) clearance?

INTRAVENOUS CATHETERS MODIFICATIONS received FDA 510(k) clearance on 1993-05-17, under 510(k) number K921295.

Who is the listed applicant for INTRAVENOUS CATHETERS MODIFICATIONS?

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

What is the FDA product code for INTRAVENOUS CATHETERS MODIFICATIONS?

The FDA product code for INTRAVENOUS CATHETERS MODIFICATIONS is FGO.

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Other records listing Critikon Company, LLC 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.

K002248DINAMAP PRO 1000 MONITOR, MODEL 1000K000500DINAMAP ADVANCED NIBP MODULEK992638DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400K982342DINAMAP MPS SELECT PORTABLE MONITORK943709DINAMAP PLUS VITAL SIGNS MONOITORK942700DINAMAP VITAL SIGNS MONITOR MODELS 9300 AND 9320/9340

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Related Devices (Code: FGO)

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.

K001563SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SETScion Cardiovascular, Inc.K970121STONE DISLODGER, BASKETBoston Scientific CorpK963750RETRIEVAL SNAREBoston Scientific CorpK962676DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICEUnited States Endoscopy Group, Inc.K951309STONE DISLODGER, BASKETBoston Scientific CorpK933261GRASPING FORCEPSSurgitek

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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