Cleared Traditional

K932211 - PROCEDURAL TRAY FOR PERIPHERALLY INSERT...

K932211 is the FDA 510(k) clearance for PROCEDURAL TRAY FOR PERIPHERALLY INSERT... by Pharmacia Deltec, Inc.. It is a Class 2 General Hospital device (product code LJS) cleared through the Traditional 510(k) pathway after a 360-day FDA review.

K932211 · Pharmacia Deltec, Inc. · General Hospital
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May 1994
Decision
360d
Days
Class 2
Risk

K932211 is an FDA 510(k) clearance for the PROCEDURAL TRAY FOR PERIPHERALLY INSERTED VENOUS. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Pharmacia Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on May 2, 1994 after a review of 360 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Pharmacia Deltec, Inc. devices

Submission Details

510(k) Number K932211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1993
Decision Date May 02, 1994
Days to Decision 360 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
231d slower than avg
Panel avg: 129d · This submission: 360d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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 - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 183
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K932211.
STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMS
K945956 · Strato Medical Corp. · Jun 1995
STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS
K946250 · Strato Medical Corp. · May 1995
PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH
K932198 · Pharmacia Deltec, Inc. · May 1994
DUAL LUMEN PERIPHERALLY INSERTED VENOUS CATHETER
K932430 · Pharmacia Deltec, Inc. · May 1994
PHERIPHERALLY INSERTED VENOUS CATHETER-Y SITE
K932433 · Pharmacia Deltec, Inc. · May 1994
PERIPHERALLYINSRTED VENOUS CATH. ALTERNATE CATH.
K932464 · Pharmacia Deltec, Inc. · May 1994