Cleared Traditional

K910116 - TURBO SUPPORT CATHETER

K910116 is an FDA 510(k) clearance for TURBO SUPPORT CATHETER, manufactured by Datascope Corp.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K910116 · Datascope Corp. · Cardiovascular device
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Jun 1991
Decision
166d
Days
Class 2
Risk

K910116 is an FDA 510(k) clearance for the TURBO SUPPORT CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Datascope Corp. (Oakland, US). The FDA issued a Cleared decision on June 25, 1991 after a review of 166 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Datascope Corp. devices

FDA 510(k) Submission Details - K910116

510(k) Number K910116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1991
Decision Date June 25, 1991
Days to Decision 166 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 125d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 725
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K910116.
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SOFTTOUCH(R) GUIDING CATHETER
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CATHCAP, CAT. NO. CC100 SERIES
K911519 · Gish Biomedical, Inc. · May 1991
NEW USCI 7F PTCA GUIDING CATHETER
K905249 · C.R. Bard, Inc. · Feb 1991
IRRIGATION CATHETER 4, 6 AND 10 FRENCH
K902256 · Applied Vascular Devices, Inc. · Feb 1991