KEY CHAIN EMERGENCY AIRWAY
FDA 510(k) clearance K962312 · decided 1997-06-17
Clearance details
- K-number
- K962312
- Device name
- KEY CHAIN EMERGENCY AIRWAY
- Applicant
- Ffrench Pocket Emergency Airway, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-06-17
- Decision date
- 1997-06-17
- Days to decision
- 365 days
- Clearance type
- Traditional
- Product code
- BWC
- Device class
- 2
- Regulation number
- 868.5090
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- New Orleans, LA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ScalpelCric (K200190) | VBM Medizintechnik GmbH | 2020-10-30 |
| Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set (K160200) | Cook Incorporated | 2017-02-17 |
| Emergency Transtracheal Airway Catheter (K153761) | Cook Incorporated | 2016-09-22 |
| RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET (K130405) | Teleflex Medical | 2013-11-06 |
| PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT (K050166) | Smiths Medical | 2005-05-26 |
| ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET (K013241) | Cook, Inc. | 2002-02-21 |
| PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET (K013252) | Cook, Inc. | 2002-02-21 |
| MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET (K013916) | Cook, Inc. | 2001-12-20 |
| MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER (K010016) | Cook, Inc. | 2001-10-09 |
| ABELSON CRICOTHYROTOMY CANNULA (K952401) | Gilbert Surgical Instruments, Inc. | 1995-07-11 |
| 31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE (K853345) | 31st. Centruy Medical Corp. | 1985-10-01 |
| WEISS EMERGENCY AIRWAY SYSTEM (K790650) | Intl. Medical Devices , Ltd. | 1979-06-27 |
Recalls involving this device
No recalls on record reference this clearance.