Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip
FDA 510(k) clearance K162729 · decided 2017-08-11
Clearance details
- K-number
- K162729
- Device name
- Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip
- Applicant
- Cook Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2016-09-29
- Decision date
- 2017-08-11
- Days to decision
- 316 days
- Clearance type
- Traditional
- Product code
- BSR
- Device class
- 1
- Regulation number
- 868.5790
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Bloomington, IN, 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 |
|---|---|---|
| TRACHLIGHT STYLET AND TRACHEAL LIGHTWAND (K962361) | Laerdal Medical Corp. | 1996-09-05 |
| TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND) (K954771) | Laerdal Medical Corp. | 1996-05-09 |
| MOLLOY INTUBATING STYLETTE (K943104) | Molloy Corp. | 1996-04-18 |
| RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE (K955238) | Rusch Intl. | 1996-02-06 |
| LIGHTED FLEXGUIDE (MODIFICATION) (K953677) | Scientific Sales Intl., Inc. | 1995-08-25 |
| RUSCH ENDOTRACHEAL TUBE STYLET (K952100) | Rusch, Inc. | 1995-08-08 |
| SCHROEDER ORAL/NASAL DIRECTIONAL STYLETTE (K952266) | Stebar Instrument Corp. | 1995-06-12 |
| AIRGUIDE STYLETTE (K950713) | Polamedco, Inc. | 1995-05-17 |
| FLEXTITIP STYLETTE (K950380) | Polamedco, Inc. | 1995-02-10 |
| STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE (K944729) | Coast Medical, Inc. | 1994-12-21 |
| FLEXGUIDE (K940799) | Scientific Sales Intl., Inc. | 1994-08-18 |
| ENDOSTAR(TM) STYLET (K933598) | Fiberoptic Medical Products, Inc. | 1994-01-25 |
Recalls involving this device
No recalls on record reference this clearance.
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 |