inforMED
OFLClass II

Percutaneous Sheath Introducer Kit

Cardiovascular · 21 CFR 870.1340

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

MDR events47All time
Recalls5All time
Registered firms19Currently listed
510(k) clearances0All time

Recent MDR events

47 adverse event reports on file

See all →

Event type breakdown

Malfunction39
Injury8

Most-reported manufacturers

See all →
Galt Medical Corp.21Arrow International Llc12Galt Medical Corp9Argon Medical Devices1Merit Medical Systems1Merit Medical Systems Mexico1Pressure Products, Inc.1Teleflex Incorporated (arrow)1

Recalls

5 recall events for this product code

See all →

Registered firms

19 firms currently registered for this product code

See all →

510(k) clearances

0 clearances for this product code

See all →

No 510(k) clearances on file for this product code.