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FDA 510(k)

AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED

K-Number: K896122 · 1990-01-19

ApplicantSpectramed, Inc.
Decision Date1990-01-19
Product CodeKXO
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED is the device name listed in this FDA 510(k) record. The listed applicant is Spectramed, Inc.. It received FDA 510(k) clearance on 1990-01-19 under 510(k) number K896122. The device is classified under product code KXO. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED?

AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED is a medical device that received FDA 510(k) clearance on 1990-01-19. The listed applicant is Spectramed, Inc.. The 510(k) number is K896122.

When did AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED receive FDA 510(k) clearance?

AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED received FDA 510(k) clearance on 1990-01-19, under 510(k) number K896122.

Who is the listed applicant for AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED?

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 AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED?

The FDA product code for AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED is KXO.

Related Clinical Trials

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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.

K892941CCO SYSTEM MODEL SP1467,SP5567,SP6267K895323MODEL DT-BAL, BALANCE SAVERK894362MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUPK881857AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.K885235SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.K881825MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH

View all 13 devices →

Related Devices (Code: KXO)

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.

K991235SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)Ludlow Technical ProductsK982565EASY TRANS TIPCarl SchuhK974730SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)Graphic Controls Corp.K964279SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)Graphic Controls Corp.K961290IUP - TIP TRANS, IUP - PROXI TRANSScientific Device Manufacturer, LLCK950498LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETERGraphic Controls 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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