Cleared Traditional

K952757 - ANGIOCATH

K952757 is an FDA 510(k) clearance for ANGIOCATH, manufactured by Becton Dickinson Vascular Access, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K952757 · Becton Dickinson Vascular Access, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
45d
Days
Class 2
Risk

K952757 is an FDA 510(k) clearance for the ANGIOCATH, NOVBALON, ANGIO-SET INTRAVASCULAR & ANGIOCATH INTRODUCTION DRAINAG.... Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Becton Dickinson Vascular Access, Inc. (Sandy, US). The FDA issued a Cleared decision on July 31, 1995 after a review of 45 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital 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 Becton Dickinson Vascular Access, Inc. devices

FDA 510(k) Submission Details - K952757

510(k) Number K952757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1995
Decision Date July 31, 1995
Days to Decision 45 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 129d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 299
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K952757.
VITAL SIGNS SALINE VASCULAR ACCESS FLUSH DEVICE
K952645 · Vital Signs, Inc. · Dec 1995
VITAL SIGNS HEPARIN VASCULAR ACCESS FLUSH DEVICE
K953120 · Vital Signs, Inc. · Dec 1995
STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE
K952058 · Trinity Laboratories, Inc. · Sep 1995
ANGIOCATH & INSYTE AUTOGUARD CATHETERS
K952861 · Becton Dickinson Vascular Access, Inc. · Jul 1995
BIONECTOR
K941678 · Vygon Corp. · Jun 1995
SIMS DELTEC, INC. CATHETER REPLACEMENT CONNECTOR
K950284 · Sims Deltec, Inc. · May 1995