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FDA 510(k)

TEFLON FEMORAL CATHETER MWI 100,10 &

K-Number: K831828 · 1983-07-07

ApplicantMed-West, Inc.
Decision Date1983-07-07
Product CodeLFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TEFLON FEMORAL CATHETER MWI 100,10 & is the device name listed in this FDA 510(k) record. The listed applicant is Med-West, Inc.. It received FDA 510(k) clearance on 1983-07-07 under 510(k) number K831828. The device is classified under product code LFK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEFLON FEMORAL CATHETER MWI 100,10 &?

TEFLON FEMORAL CATHETER MWI 100,10 & is a medical device that received FDA 510(k) clearance on 1983-07-07. The listed applicant is Med-West, Inc.. The 510(k) number is K831828.

When did TEFLON FEMORAL CATHETER MWI 100,10 & receive FDA 510(k) clearance?

TEFLON FEMORAL CATHETER MWI 100,10 & received FDA 510(k) clearance on 1983-07-07, under 510(k) number K831828.

Who is the listed applicant for TEFLON FEMORAL CATHETER MWI 100,10 &?

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

What is the FDA product code for TEFLON FEMORAL CATHETER MWI 100,10 &?

The FDA product code for TEFLON FEMORAL CATHETER MWI 100,10 & is LFK.

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Other records listing Med-West, 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.

K880877CONTRAST INJECTION DEVICEK880398POWER TOILET ELEVATORK874470MWI 400 WOUND DRESSINGK872724SHEATH/DILATORSK854612ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7K852162MNI 400 INJECTION CAPS

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Related Devices (Code: LFK)

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.

K971897CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATHETER 10 FR (CAVH)Medron, Inc.K914936CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SETAkcess Medical Products, Inc.K915215CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITSAkcess Medical Products, Inc.K891764FC-101 FEMORAL CATHETER GUIDE WIREAkcess Medical Products, Inc.K891763FC-100 FEMORAL CATHETERAkcess Medical Products, Inc.K890717MODIFICATION HEMOFILTRATION CATHETER HF-100Vas-Cath, 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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