Cleared Traditional

K841878 - SHEATH REMOVER

K841878 is the FDA 510(k) clearance for SHEATH REMOVER by Datascope Corp.. It is a Class 2 General Hospital device (product code LJS) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K841878 · Datascope Corp. · General Hospital

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Jul 1984

Decision

67d

Days

Class 2

Risk

K841878 is an FDA 510(k) clearance for the SHEATH REMOVER. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Datascope Corp. (Mchenry, US). The FDA issued a Cleared decision on July 13, 1984 after a review of 67 days - a notably fast clearance cycle.

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: 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 Datascope Corp. devices

Submission Details

510(k) Number	K841878 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 07, 1984
Decision Date	July 13, 1984
Days to Decision	67 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

62d faster than avg

Panel avg: 129d · This submission: 67d

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 137

Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K841878.

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DESERET LONG TERM INDWELLING CATHETER

K840958 · Parke-Davis Co. · Apr 1984

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K833442 · Quinton, Inc. · Mar 1984

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K834225 · Quinton, Inc. · Feb 1984

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K841878

Datascope Corp.

Mchenry, IL · US

Regulatory profile

136 submissions 135 cleared

99% clearance rate · Active in General Hospital

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Sourced from FDA 510(k) public files . Updated monthly.

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