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FDA 510(k)

COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH

K-Number: K103043 · 2011-01-07

ApplicantAdapta Medical, Inc.
Decision Date2011-01-07
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH is the device name listed in this FDA 510(k) record. The listed applicant is Adapta Medical, Inc.. It received FDA 510(k) clearance on 2011-01-07 under 510(k) number K103043. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH?

COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH is a medical device that received FDA 510(k) clearance on 2011-01-07. The listed applicant is Adapta Medical, Inc.. The 510(k) number is K103043.

When did COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH receive FDA 510(k) clearance?

COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH received FDA 510(k) clearance on 2011-01-07, under 510(k) number K103043.

Who is the listed applicant for COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH?

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

What is the FDA product code for COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH?

The FDA product code for COLORADO CATHETER STERILESURE - NEW NAME PERFIC CATH is EZD.

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Other records listing Adapta Medical, 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.

K161445PerfIC Cath Gel S, PerfIC Cath Gel C, PerfIC Cath Hydro S, PerfIC Cath Hydro C

Related Devices (Code: EZD)

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.

K261418Liquick X-treme, Liquick X-treme PlusTeleflex MedicalK260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).ConvatecK261658LoFric Origo Pro CoudéWellspect ABK262045Luja SoftColoplast A.S.K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd.K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister Incorporated

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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