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FDA 510(k)

SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.

K-Number: K885235 · 1989-01-25

ApplicantSpectramed, Inc.
Decision Date1989-01-25
Product CodeDSK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. is the device name listed in this FDA 510(k) record. The listed applicant is Spectramed, Inc.. It received FDA 510(k) clearance on 1989-01-25 under 510(k) number K885235. The device is classified under product code DSK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.?

SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. is a medical device that received FDA 510(k) clearance on 1989-01-25. The listed applicant is Spectramed, Inc.. The 510(k) number is K885235.

When did SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. receive FDA 510(k) clearance?

SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. received FDA 510(k) clearance on 1989-01-25, under 510(k) number K885235.

Who is the listed applicant for SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.?

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

What is the FDA product code for SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.?

The FDA product code for SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. is DSK.

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Other records listing Spectramed, 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.

K896122AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPEDK892941CCO SYSTEM MODEL SP1467,SP5567,SP6267K895323MODEL DT-BAL, BALANCE SAVERK894362MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUPK881857AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.K881825MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH

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Related Devices (Code: DSK)

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.

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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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