Cleared Traditional

K930630 - RIGHT ATRIAL CATHETER

K930630 is an FDA 510(k) clearance for RIGHT ATRIAL CATHETER, manufactured by Akcess Medical Products, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 364-day FDA review.

K930630 · Akcess Medical Products, Inc. · General Hospital
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Feb 1994
Decision
364d
Days
Class 2
Risk

K930630 is an FDA 510(k) clearance for the RIGHT ATRIAL CATHETER. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Akcess Medical Products, Inc. (New Brunswick, US). The FDA issued a Cleared decision on February 7, 1994 after a review of 364 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 Akcess Medical Products, Inc. devices

FDA 510(k) Submission Details - K930630

510(k) Number K930630 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 08, 1993
Decision Date February 07, 1994
Days to Decision 364 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
235d slower than avg
Panel avg: 129d · This submission: 364d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJS Device Classification - Class 2, Special Controls

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 260
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K930630.
ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETER
K930129 · Arrow Intl., Inc. · Mar 1994
L CATH(R) CATHETER SYSTEM
K925236 · Luther Medical Products, Inc. · Mar 1994
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K926331 · Bard Access Systems, Inc. · Mar 1994
STRATO MEDICAL LIFEPORT LPS 7255 LOW PROFILE DUAL LUMEN VASCULAR ACCESS SYSTEM
K933884 · Strato Medical Corp. · Dec 1993
STRATO MEDICAL SINGLE LUMEN VALVED CATHETER
K924851 · Strato Medical Corp. · Dec 1993
STRATO MEDICAL INFUSE-A-CATH POLYURE CEN VEN CATH
K924677 · Strato Medical Corp. · Jul 1993