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FDA 510(k)

THEREX LOW PROFILE B PORT 1.0MM I.D./1.8MM O.D. DETACHED CATHETER

K-Number: K960572 · 1996-04-26

ApplicantArrow Intl., Inc.
Decision Date1996-04-26
Product CodeLJT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THEREX LOW PROFILE B PORT 1.0MM I.D./1.8MM O.D. DETACHED CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Arrow Intl., Inc.. It received FDA 510(k) clearance on 1996-04-26 under 510(k) number K960572. The device is classified under product code LJT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THEREX LOW PROFILE B PORT 1.0MM I.D./1.8MM O.D. DETACHED CATHETER?

THEREX LOW PROFILE B PORT 1.0MM I.D./1.8MM O.D. DETACHED CATHETER is a medical device that received FDA 510(k) clearance on 1996-04-26. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K960572.

When did THEREX LOW PROFILE B PORT 1.0MM I.D./1.8MM O.D. DETACHED CATHETER receive FDA 510(k) clearance?

THEREX LOW PROFILE B PORT 1.0MM I.D./1.8MM O.D. DETACHED CATHETER received FDA 510(k) clearance on 1996-04-26, under 510(k) number K960572.

Who is the listed applicant for THEREX LOW PROFILE B PORT 1.0MM I.D./1.8MM O.D. DETACHED CATHETER?

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

What is the FDA product code for THEREX LOW PROFILE B PORT 1.0MM I.D./1.8MM O.D. DETACHED CATHETER?

The FDA product code for THEREX LOW PROFILE B PORT 1.0MM I.D./1.8MM O.D. DETACHED CATHETER is LJT.

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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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