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FDA 510(k)

ILIAC CREST BONE MARROW ASPIRATION NEEDLE

K-Number: K953082 · 1995-09-22

ApplicantBaxter Healthcare Corp
Decision Date1995-09-22
Product CodeGDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ILIAC CREST BONE MARROW ASPIRATION NEEDLE 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 1995-09-22 under 510(k) number K953082. The device is classified under product code GDM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ILIAC CREST BONE MARROW ASPIRATION NEEDLE?

ILIAC CREST BONE MARROW ASPIRATION NEEDLE is a medical device that received FDA 510(k) clearance on 1995-09-22. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K953082.

When did ILIAC CREST BONE MARROW ASPIRATION NEEDLE receive FDA 510(k) clearance?

ILIAC CREST BONE MARROW ASPIRATION NEEDLE received FDA 510(k) clearance on 1995-09-22, under 510(k) number K953082.

Who is the listed applicant for ILIAC CREST BONE MARROW ASPIRATION NEEDLE?

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 ILIAC CREST BONE MARROW ASPIRATION NEEDLE?

The FDA product code for ILIAC CREST BONE MARROW ASPIRATION NEEDLE is GDM.

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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: GDM)

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.

K071732MARROWMINERStemcor Systems, Inc.K971114BIOACCESS MARROW HARVEST SYSTEMBioaccess, Inc.K953064BIOACCESS MARROW HARVEST SYSTEMBioaccess, Inc.K936207ENDO-NEEDLE INSTRUMENTGerard Medical, Inc.K930160ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLESymbiosis Corp.K923872BONE MARROW BIOPSY SYSTEMThe Straumann Co.

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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