Percutaneous Introducer Kit
General Hospital · 21 CFR 880.5570
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
1 recall events for this product code
Registered firms
13 firms currently registered for this product code
Cardinal Health 200, Llc
Waukegan, IL, US
Isomedix Operations Inc
El Paso, TX, US
Sterigenics Us Llc
Grand Prairie, TX, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Sterigenics U.s., Llc
Charlotte, NC, US
Vygon Mfg
DOVER, NH, US
Mainstream Medical Devices
Austin, TX, US
Zien Medical Technologies Llc
Salt Lake City, UT, US
Midwest Sterilization Corp.
JACKSON, MO, US
Cardinal Health 200, Llc
El Paso, TX, US
Isomedix Operations Inc
EL PASO, TX, US
Midwest Sterilization Corp.
LAREDO, TX, US
Arrow Internacional De Chihuahua S.a. De C.v.
CHIHUAHUA, MX
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.