Vascular Access Port Kit
General Hospital · 21 CFR 880.5965
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
3 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
10 firms currently registered for this product code
Isomedix Operations Inc
EL PASO, TX, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Arrow Internacional De Chihuahua S.a. De C.v.
CHIHUAHUA, MX
Sterigenics U.s., Llc
Charlotte, NC, US
Midwest Sterilization Corp.
JACKSON, MO, US
Cardinal Health 200, Llc
Waukegan, IL, US
Pfm Medical, Inc
Carlsbad, CA, US
Cardinal Health 200, Llc
El Paso, TX, US
Isomedix Operations Inc
El Paso, TX, US
Sterigenics Us Llc
Grand Prairie, TX, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.