510(k) K050166
- Device
- PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT
- Applicant
- SMITHS MEDICAL
- 510(k) number
- K050166
- Product code
- BWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-05-26
- Date received
- 2005-01-26
- Regulation
- 868.5090
- Classification name
- Needle, Emergency Airway
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHRISTOPHER TURNBULL
- Address
- Military Rd. Hythe, Kent GB CT 21 5BN CT 21 5BN
FDA Registration Numbers#
- 1000393132
- 3013557562
- 3012307300
- 3030446844
- 3030447506
- 3030733800
- 1820334
- 3011237704
- 8010939
- 3005941719
- 9617604
- 3012542015
- 2320200
- 3009039068
Source Documents#
Other 510(k) Records For Product Code BWC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200190 | ScalpelCric | VBM Medizintechnik GmbH | 2020-10-30 |
| K160200 | Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set | Cook Incorporated | 2017-02-17 |
| K153761 | Emergency Transtracheal Airway Catheter | Cook Incorporated | 2016-09-22 |
| K130405 | RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET | Teleflex Medical | 2013-11-06 |
| K013241 | ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET | Cook, Inc. | 2002-02-21 |
| K013252 | PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET | Cook, Inc. | 2002-02-21 |
| K013916 | MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET | Cook, Inc. | 2001-12-20 |
| K010016 | MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER | Cook, Inc. | 2001-10-09 |
| K962312 | KEY CHAIN EMERGENCY AIRWAY | Ffrench Pocket Emergency Airway, Inc. | 1997-06-17 |
| K952401 | ABELSON CRICOTHYROTOMY CANNULA | Gilbert Surgical Instruments, Inc. | 1995-07-11 |
| K853345 | 31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE | 31st. Centruy Medical Corp. | 1985-10-01 |
| K790650 | WEISS EMERGENCY AIRWAY SYSTEM | Intl. Medical Devices , Ltd. | 1979-06-27 |
| K771587 | INSTANT AIR | Hyde, Vernon E., D.D.S. | 1977-09-02 |
Legacy Summary#
summary
FDA Review#
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