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FDA 510(k)

AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.

K-Number: K881857 · 1989-02-01

ApplicantSpectramed, Inc.
Decision Date1989-02-01
Product CodeKXO
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU. is the device name listed in this FDA 510(k) record. The listed applicant is Spectramed, Inc.. It received FDA 510(k) clearance on 1989-02-01 under 510(k) number K881857. 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 AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.?

AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU. is a medical device that received FDA 510(k) clearance on 1989-02-01. The listed applicant is Spectramed, Inc.. The 510(k) number is K881857.

When did AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU. receive FDA 510(k) clearance?

AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU. received FDA 510(k) clearance on 1989-02-01, under 510(k) number K881857.

Who is the listed applicant for AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.?

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 AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.?

The FDA product code for AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU. is KXO.

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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 IUPK885235SAFE-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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