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FDA 510(k)

4-SURE NELATON CATHETER

K-Number: K931048 · 1994-02-14

ApplicantBoston Pacific Medical, Inc.
Decision Date1994-02-14
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

4-SURE NELATON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Pacific Medical, Inc.. It received FDA 510(k) clearance on 1994-02-14 under 510(k) number K931048. 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 4-SURE NELATON CATHETER?

4-SURE NELATON CATHETER is a medical device that received FDA 510(k) clearance on 1994-02-14. The listed applicant is Boston Pacific Medical, Inc.. The 510(k) number is K931048.

When did 4-SURE NELATON CATHETER receive FDA 510(k) clearance?

4-SURE NELATON CATHETER received FDA 510(k) clearance on 1994-02-14, under 510(k) number K931048.

Who is the listed applicant for 4-SURE NELATON CATHETER?

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

What is the FDA product code for 4-SURE NELATON CATHETER?

The FDA product code for 4-SURE NELATON CATHETER is EZD.

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Other records listing Boston Pacific 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.

K9331094SURE URO-LINK UROLOGICAL PROCEDURE TRAYSK9224024 SURE TM ENTERAL FEEDING BAGK9310474-SURE FEMALE CATHETERK9218524 SURE TM RECTAL TUBEK9218534 SURE TM FEEDING TUBESK9218514 SURE TM SUCTION CATHETERS & KITS

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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

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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