Class Class II

Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) (K242212)

K242212 2024-08-27 Traditional
Home/ Devices/ Disposable Syringe (Kit); Nemoto…

Description

Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) by Nemoto Kyorindo Co., Ltd., an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242212
Clearance Date2024-08-27
Clearance TypeTraditional
Product CodeDXT
Regulation Number870.1650

Categories

Need More Information?

Contact the manufacturer or request a quote for this device.

Request Quote

Predicate lineage for K242212

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) (K242212) cites 3 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K120892DISPOSABLE 330PSI EXTENSION LINESCoeur, Inc.2013
K090487DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOG...Coeur, Inc.2009
K051799DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORSCoeur, Inc.2005

Trace the full predicate network for K242212

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

Scroll to Top