Cleared Traditional

K925533 - ANGESTAT PERICARDIAL DRAINAGE SHEATH SET

K925533 is an FDA 510(k) clearance for ANGESTAT PERICARDIAL DRAINAGE SHEATH SET, manufactured by Angeion Corp.. The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K925533 · Angeion Corp. · General & Plastic Surgery device
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Jan 1993
Decision
71d
Days
Class 1
Risk

K925533 is an FDA 510(k) clearance for the ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Angeion Corp. (Plymouth, US). The FDA issued a Cleared decision on January 12, 1993 after a review of 71 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Angeion Corp. devices

FDA 510(k) Submission Details - K925533

510(k) Number K925533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1992
Decision Date January 12, 1993
Days to Decision 71 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 115d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

GBX Device Classification - Class 1, General Controls

Product Code GBX Catheter, Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GBX Catheter, Irrigation

All 34
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K925533.
KENDALL WOUND DRAINAGE SYSTEMS-TROCARS
K925805 · Kendall Healthcare Products Co. Div.Of Tyco Health · Feb 1993
KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN
K925748 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jan 1993
TURKEL ABDOMINAL PARACENTESIS SYSTEM
K924702 · Symbiosis Corp. · Jan 1993
SIL-MED FLAT SUCTION DRAIN
K921424 · Sil-Med Corp. · Sep 1992
HOLLISTER HORIZONTAL DRAIN/TUBE ATTACHMENT DEVICE
K922739 · Hollister, Inc. · Aug 1992
I/A HANDPIECE WITH REPLACEABLE TIPS
K910245 · Surgical Technologies, Inc. · Apr 1991