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FDA 510(k)

PVC ABDOMINAL/RECTAL PRESSURE CATHETER

K-Number: K954315 · 1995-11-30

ApplicantLife-Tech Intl., Inc.
Decision Date1995-11-30
Product CodeFEN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PVC ABDOMINAL/RECTAL PRESSURE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Life-Tech Intl., Inc.. It received FDA 510(k) clearance on 1995-11-30 under 510(k) number K954315. The device is classified under product code FEN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PVC ABDOMINAL/RECTAL PRESSURE CATHETER?

PVC ABDOMINAL/RECTAL PRESSURE CATHETER is a medical device that received FDA 510(k) clearance on 1995-11-30. The listed applicant is Life-Tech Intl., Inc.. The 510(k) number is K954315.

When did PVC ABDOMINAL/RECTAL PRESSURE CATHETER receive FDA 510(k) clearance?

PVC ABDOMINAL/RECTAL PRESSURE CATHETER received FDA 510(k) clearance on 1995-11-30, under 510(k) number K954315.

Who is the listed applicant for PVC ABDOMINAL/RECTAL PRESSURE CATHETER?

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

What is the FDA product code for PVC ABDOMINAL/RECTAL PRESSURE CATHETER?

The FDA product code for PVC ABDOMINAL/RECTAL PRESSURE CATHETER is FEN.

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Other records listing Life-Tech Intl., 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.

K001129PROLONG, MODELS PL50, PL100, PL150K955031MAXISTIMK954505EZ STIMK954341URODYNAMICS TUBING AND INFUSION SETSK953451UROPUMP TUBE & DAMPING CHAMGERK953353UROVISION JANUS

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Related Devices (Code: FEN)

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.

K212830CT3000ProSrs MedicalK082701URONIRS, MODEL 2000Urodynamix Technologies, Ltd.K073552LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORYLaborie Medical Technologies, Corp.K001386ACCUSET SENSOR, MODEL 2000Pelvicare, Inc.K992715NEURO URODYNAMIC SUITE, MODEL 9032E0101Medtronic Functional Diagnostics A/SK983325IN-PROBE II URODYNAMIC SYSTEMInfluence, 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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