PERIMETER THORACIC CATHETER— 510(k) K844922

Name: FDA 510(k) clearance K844922
Creator: U.S. Food and Drug Administration
Published: 1985-03-18

Substantially Equivalent

Perimeter Medical, Inc.

FDA 510(k) clearance K844922 for PERIMETER THORACIC CATHETER, Substantially Equivalent on 1985-03-18. Applicant: Perimeter Medical, Inc.. Device class: 1.

Clearance details

Applicant: Perimeter Medical, Inc.
Product code: Code GBX
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1984-12-19
Decision date: 1985-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GBX

view all

K131659 — MOERAE VEIN PREPARATION KIT2014-03-03
K082725 — GRAFTGUARD PRESSURE CONTROLLING SYRINGE2008-12-17
K052286 — DEUTSCH ANTI-BLOCKAGE WOUND DRAIN2005-10-21
K043515 — GRAFTSAVER2005-03-31
K013417 — MISONIX IRRIGATION SYSTEM MOEDL BC20P2002-01-10

More clearances from Perimeter Medical, Inc.

view all

K844921 — PERIMETER CLOSED WOUND RESEVOIR1985-03-18
K844923 — PERIMETER SUMP DRAIN1985-03-18
K844924 — PERIMETER YANKAUER SUCTION TIPS & SETS1985-03-18
K844925 — PERIMETER MEDIASTINAL DRAIN1985-03-18

Adverse events under product code GBX

product code GBX

Death: 16
Injury: 583
Malfunction: 3,578
Other: 1
Total: 4,178

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.