Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set
FDA 510(k) clearance K160200 · decided 2017-02-17
Clearance details
- K-number
- K160200
- Device name
- Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set
- Applicant
- Cook Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2016-01-28
- Decision date
- 2017-02-17
- Days to decision
- 386 days
- Clearance type
- Traditional
- Product code
- BWC
- Device class
- 2
- Regulation number
- 868.5090
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bloomington, IN, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| ScalpelCric (K200190) | VBM Medizintechnik GmbH | 2020-10-30 |
| 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 |
| KEY CHAIN EMERGENCY AIRWAY (K962312) | Ffrench Pocket Emergency Airway, Inc. | 1997-06-17 |
| 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
| Record | Firm | Date |
|---|---|---|
| Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCC recall (Z-1785-2026) | Cook Incorporated | 2026-04-06 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S005) | Cook Incorporated | 2009-04-02 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S006) | Cook Incorporated | 2009-03-05 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S004) | Cook Incorporated | 2008-05-08 |
| COOK CHORIONIC VILLUS SAMPLING (CVS) SET (P900007/S002) | Cook Incorporated | 2000-06-12 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S001) | Cook Incorporated | 1998-07-08 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007) | Cook Incorporated | 1994-09-30 |