Suction Catheter Kit
General, Plastic Surgery · 21 CFR 878.4200
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
1 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
11 firms currently registered for this product code
Sterigenics Us Llc
Grand Prairie, TX, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Cardinal Health 200, Llc
Waukegan, IL, US
Sterigenics U.s., Llc
Charlotte, NC, US
Bound Tree Medical, Llc
Grand Prairie, TX, US
Isomedix Operations Inc
El Paso, TX, US
Isomedix Operations Inc
EL PASO, TX, US
Arrow Internacional De Chihuahua S.a. De C.v.
CHIHUAHUA, MX
Cardinal Health 200, Llc
El Paso, TX, US
Poly Medicure Ltd
Jaipur Rajasthan, IN
Henan Yadu Industrial Co.,ltd
ChangYuan Henan, CN
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.