Perimeter Thoracic Catheter

FDA 510(k) K844922 · Perimeter Medical, Inc.

Substantially Equivalent

510(k) numberK844922

Submission

Device name
Perimeter Thoracic Catheter
Applicant
Perimeter Medical, Inc.
Tucson, AZ, US
Received
December 19, 1984
Decision date
March 18, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GBX – Catheter, Irrigation
Device class
Class I (low risk)
Regulation
21 CFR 878.4200
Specialty
General, Plastic Surgery

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K973703Jackson-Pratt Hemaduct Wound Drain, Jackson-Pratt Gold Hemaduct Wound DrainGBX · Traditional Allegiance Healthcare Corp.12/04/1997SE
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More from Axiom Medical, Inc.

510(k)DeviceDecision
K844925Perimeter Mediastinal Drain · Traditional 03/18/1985SE
K844924Perimeter Yankauer Suction Tips & Sets · Traditional 03/18/1985SE
K844923Perimeter Sump Drain · Traditional 03/18/1985SE
K844921Perimeter Closed Wound ResevoirGCY · Traditional 03/18/1985SE

Questions and answers

When was Perimeter Thoracic Catheter cleared by the FDA?

Perimeter Thoracic Catheter (K844922) received a 510(k) decision of Substantially Equivalent on March 18, 1985, 89 days after the submission was received.

What is the product code of K844922?

The FDA product code is GBX – Catheter, Irrigation, a Class I (low risk) device regulated under 21 CFR 878.4200.