Cricothyrotomy Kit
Anesthesiology · 21 CFR 868.5800
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
Recent MDR events
5 adverse event reports on file
- PORTEX MINI-TRACH LL CRICOTHYROIDOTOMY KITJan 3, 2025InjurySmiths Medical International Ltd.3010189764-2025-00001
- MINI-TRACH II SELDINGER 4.0MM CRICOTHYROIDOTOMY KITDec 6, 2018MalfunctionSmiths Medical Asd, Inc.3012307300-2018-08564
- PORTEX MINI-TRACH II - NON SELDINGER KITJun 29, 2018MalfunctionSmiths Medical Asd; Inc.3012307300-2018-02525
- PORTEX MINI-TRACH II - NON SELDINGER KITMay 15, 2018MalfunctionSmiths Medical Asd, Inc.3012307300-2018-01420
- PORTEX MINI-TRACH II - NON SELDINGER KITApr 4, 2018MalfunctionSmiths Medical, Asd, Inc.3012307300-2018-00663
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
19 firms currently registered for this product code
Isomedix Operations Inc
EL PASO, TX, US
Sterigenics U.s., Llc
Charlotte, NC, US
Faretec, Inc.
Painesville, OH, US
Well Lead Medical Co. Ltd
GUANGZHOU Guangdong, CN
Midwest Sterilization Corp.
LAREDO, TX, US
Synchronis Medical Llc
Romulus, MI, US
North American Rescue, Llc.
Greer, SC, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Isomedix Operations Inc
El Paso, TX, US
Tacmed Solutions, Llc
Anderson, SC, US
Cardinal Health 200, Llc
Waukegan, IL, US
Bound Tree Medical, Llc
Grand Prairie, TX, US
Sterigenics Us Llc
Grand Prairie, TX, US
Chinook Medical Gear, Inc.
Tulsa, OK, US
Specialty Medical Products Co.
N Salt Lake, UT, US
Midwest Sterilization Corp.
JACKSON, MO, US
Safeguard Us Operating, Llc
Huntersville, NC, US
Cardinal Health 200, Llc
El Paso, TX, US
Nar Medical Depot, Llc
Greer, SC, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.