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FDA 510(k)

ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II.

K-Number: K952470 · 1995-11-28

ApplicantR-Group Intl.
Decision Date1995-11-28
Product CodeGCD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. is the device name listed in this FDA 510(k) record. The listed applicant is R-Group Intl.. It received FDA 510(k) clearance on 1995-11-28 under 510(k) number K952470. The device is classified under product code GCD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II.?

ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. is a medical device that received FDA 510(k) clearance on 1995-11-28. The listed applicant is R-Group Intl.. The 510(k) number is K952470.

When did ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. receive FDA 510(k) clearance?

ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. received FDA 510(k) clearance on 1995-11-28, under 510(k) number K952470.

Who is the listed applicant for ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II.?

The FDA 510(k) record lists R-Group Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II.?

The FDA product code for ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. is GCD.

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Other records listing R-Group Intl. 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.

K001233ACTI-FLEX FLUID DELIVERY SYSTEM OR ACTI-FLEX F D SK001599ACTI-FLEX IV ADMINISTRATION SETK993777DISPOSABLE AND REUSABLE BALL AND LOOP ELECTRODESK954035ACTI-FLEX ARTERIAL EXTENSION SETK940319R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINEK913267R-GROUP INTL. ONE WALL PUNCTURE NEEDLE

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Related Devices (Code: GCD)

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.

K940198L-CATH CONNECTOR ASSEMBLYLuther Medical Products, Inc.K863446ANGIOMED HIGH PRESSURE CONNECTORSAngiomed U.S., Inc.K851196INCISION DRAINSil-Med Corp.K851921Y CONNECTORSil-Med Corp.K760382CONNECTORSB. Braun InstrumentsK760524CATHETER CONNECTOR, ARGYLE TUBINGSherwood Medical Industries

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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