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FDA 510(k)

IV PREP KIT W/O DRESSING (NON-STERILE)

K-Number: K925018 · 1993-08-27

ApplicantCustomed, Inc.
Decision Date1993-08-27
Product CodeLRS
Advisory CommitteeHO
DecisionUnknown

Device Summary

IV PREP KIT W/O DRESSING (NON-STERILE) is the device name listed in this FDA 510(k) record. The listed applicant is Customed, Inc.. It received FDA 510(k) clearance on 1993-08-27 under 510(k) number K925018. The device is classified under product code LRS. It was reviewed by the HO advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the IV PREP KIT W/O DRESSING (NON-STERILE)?

IV PREP KIT W/O DRESSING (NON-STERILE) is a medical device that received FDA 510(k) clearance on 1993-08-27. The listed applicant is Customed, Inc.. The 510(k) number is K925018.

When did IV PREP KIT W/O DRESSING (NON-STERILE) receive FDA 510(k) clearance?

IV PREP KIT W/O DRESSING (NON-STERILE) received FDA 510(k) clearance on 1993-08-27, under 510(k) number K925018.

Who is the listed applicant for IV PREP KIT W/O DRESSING (NON-STERILE)?

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

What is the FDA product code for IV PREP KIT W/O DRESSING (NON-STERILE)?

The FDA product code for IV PREP KIT W/O DRESSING (NON-STERILE) is LRS.

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Other records listing Customed, 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.

K974647FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633K971920GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)K964011SUCTION CATHETER TRAY PRODUCT NO. 900277K962652URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)K962596CUSTOMED BLOOD EXTRACTION KITK961442UNIVERSAL DRAINAGE TRAY

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Related Devices (Code: LRS)

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.

K050654AMSINO I.V. START KITAmsino International, Inc.K001879INFUSION IV SETNirvi Intl. USAK963722IV START KITGrand Medical ProductsK951167EMS I.V. START KITEmergency Medical Supply, Inc.K950184B. BRAUN IV START KITSB. Braun of America, Inc.K944041PERSONAL HEARING SYSTEMResound Corp.

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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