SNIPER, MODEL OR-3872XX SERIES— 510(k) K001251

Name: FDA 510(k) clearance K001251
Creator: U.S. Food and Drug Administration
Published: 2000-07-07

Substantially Equivalent

Nipro Medical Corp.

FDA 510(k) clearance K001251 for SNIPER, MODEL OR-3872XX SERIES, Substantially Equivalent on 2000-07-07. Applicant: Nipro Medical Corp.. Device class: 2.

Clearance details

Applicant: Nipro Medical Corp.
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 2000-04-19
Decision date: 2000-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Athens, TX, US

Download summary PDF View on FDA.gov ↗

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K254137 — InQwire Amplatz Guide Wire2026-05-22
K260544 — FMD Peripheral Guide Wire F-14 Flex 6 +4 more2026-03-20

More clearances from Nipro Medical Corp.

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K093985 — NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE2010-01-22
K081210 — NIPRO SAFETOUCH HUBER INFUSTION SET2008-10-21
K072024 — NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M96932007-10-04
K063368 — NIPRO BIOHOLE NEEDLE2007-02-05
K063721 — NIPRO SAFETOUCH II GAMMA2007-01-12

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K001251

K-number listed on FDA's recall record

Z-0134-2013 — AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.Class II·Terminated·Nipro Medical Corporation·20120727
Z-0135-2013 — AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.Class II·Terminated·Nipro Medical Corporation·20120727
Z-0136-2013 — AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.Class II·Terminated·Nipro Medical Corporation·20120727
Z-0137-2013 — AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.Class II·Terminated·Nipro Medical Corporation·20120727
Z-0138-2013 — AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.Class II·Terminated·Nipro Medical Corporation·20120727

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K001251.

Data sourced from openFDA. This site is unofficial and independent of the FDA.