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FDA 510(k)

CONVERTORS SAFECARE GOWN & DRAPE MATERIAL

K-Number: K913506 · 1991-10-11

ApplicantBaxter Healthcare Corp
Decision Date1991-10-11
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CONVERTORS SAFECARE GOWN & DRAPE MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1991-10-11 under 510(k) number K913506. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONVERTORS SAFECARE GOWN & DRAPE MATERIAL?

CONVERTORS SAFECARE GOWN & DRAPE MATERIAL is a medical device that received FDA 510(k) clearance on 1991-10-11. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K913506.

When did CONVERTORS SAFECARE GOWN & DRAPE MATERIAL receive FDA 510(k) clearance?

CONVERTORS SAFECARE GOWN & DRAPE MATERIAL received FDA 510(k) clearance on 1991-10-11, under 510(k) number K913506.

Who is the listed applicant for CONVERTORS SAFECARE GOWN & DRAPE MATERIAL?

The FDA 510(k) record lists Baxter Healthcare Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONVERTORS SAFECARE GOWN & DRAPE MATERIAL?

The FDA product code for CONVERTORS SAFECARE GOWN & DRAPE MATERIAL is KKX.

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Other records listing Baxter Healthcare Corp as applicant

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K190910PrisMax System Version 2K163530PrisMax Control UnitK132734NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETSK130245LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFOK123874INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL SK123868INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET

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Related Devices (Code: KKX)

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.

K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M CompanyK202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie BvbaK200238ControlRad Sterile CoverControlrad, Inc.K163556MediClear PreOpCovalontechnologies, Inc.K130404TIBURON SURGICAL DRAPECardinal Health200, LLC

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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