ARGYLE TAUSSIG CULTURE CATHETER
FDA 510(k) clearance K791327 · decided 1979-08-22
Clearance details
- K-number
- K791327
- Device name
- ARGYLE TAUSSIG CULTURE CATHETER
- Applicant
- Sherwood Medical Co.
- Decision
- Substantially Equivalent
- Date received
- 1979-07-16
- Decision date
- 1979-08-22
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- KTR
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Mchenry, IL, 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 |
|---|---|---|
| BAL CATH (K923487) | Ballard Medical Products | 1993-07-30 |
| RIGID SUCTION TIPS (K822255) | Kelleher Corp. | 1982-08-25 |
| ARGYLE DELEE SUCTION CATHETER W/MUCOUS (K820572) | Sherwood Medical Co. | 1982-04-09 |
Recalls involving this device
No recalls on record reference this clearance.