FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM
FDA 510(k) clearance K971348 · decided 1998-02-27
Clearance details
- K-number
- K971348
- Device name
- FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM
- Applicant
- Green Field Medical Sourcing, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-04-10
- Decision date
- 1998-02-27
- Days to decision
- 323 days
- Clearance type
- Traditional
- Product code
- CAO
- Device class
- 2
- Regulation number
- 868.5650
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Shrewsbury, MA, 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 |
|---|---|---|
| EVAC-TUBE (K894032) | Sharn, Inc. | 1989-08-31 |
| ESOPHAGEAL OBTURATOR/TRACHEAL TUBE (K875226) | Sheridan Catheter Corp. | 1988-01-19 |
| VETA/VENTED ESOPHAGEAL TUBE AIRWAY (K864200) | Cranco Co. | 1987-03-17 |
| RESPIRONICS PTL REVIVEEASY (K863172) | Respironics, Inc. | 1986-11-04 |
| ESOPHAGEAL OBTURATION AIRWAY (K761195) | Mckesson Corp. | 1976-12-09 |
Recalls involving this device
No recalls on record reference this clearance.