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FDA 510(k)

AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS

K-Number: K932408 · 1993-09-28

ApplicantBaxter Healthcare Corp
Decision Date1993-09-28
Product CodeFFN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS 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 1993-09-28 under 510(k) number K932408. The device is classified under product code FFN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS?

AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS is a medical device that received FDA 510(k) clearance on 1993-09-28. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K932408.

When did AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS receive FDA 510(k) clearance?

AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS received FDA 510(k) clearance on 1993-09-28, under 510(k) number K932408.

Who is the listed applicant for AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS?

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 AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS?

The FDA product code for AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS is FFN.

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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: FFN)

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.

K892550BEST COLON CLAMPZinnanti Surgical Instruments, Inc.K892542RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEUZinnanti Surgical Instruments, Inc.K772405TUBING CLAMPFred Sammons, Inc.K771421CATHETEO CLAMPQuinton, Inc.

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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