WILTEK IRRIGAITON/ASPIRATION TUBE SET
FDA 510(k) clearance K922989 · decided 1994-02-15
Clearance details
- K-number
- K922989
- Device name
- WILTEK IRRIGAITON/ASPIRATION TUBE SET
- Applicant
- Wiltek Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-22
- Decision date
- 1994-02-15
- Days to decision
- 603 days
- Clearance type
- Traditional
- Product code
- BYY
- Device class
- 2
- Regulation number
- 880.6740
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Winston-Salem, NC, 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 |
|---|---|---|
| VITAFLOW SUCTION/ASPIRATION TUBING SET (K960616) | Vital Concepts, Inc. | 1996-05-06 |
| CONNECTING TUBING (K960218) | Custom Pack Reliability | 1996-03-28 |
| MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL (K955149) | Bio-Medical Devices, Inc. | 1996-01-24 |
| MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR (K955151) | Bio-Medical Devices, Inc. | 1996-01-24 |
| MAXI-FLOW (K955150) | Bio-Medical Devices, Inc. | 1996-01-23 |
| GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC) (K911586) | Megadyne Medical Products, Inc. | 1991-07-02 |
| STERILE SUCTION TUBING SET (K901761) | Acacia Laboratories, Inc. | 1990-05-07 |
| VAN DELLEN ASPIRATING TUBING (K873463) | Van Dellen, Ltd. | 1987-11-23 |
| EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN (K853296) | Parexel Intl. Corp. | 1985-08-15 |
| PHARMA-PLAST CONNECTING TUBE TYPE SUCT- (K843470) | Zimmar Consulting , Ltd. | 1984-11-16 |
| FLEX BUBBLE TUBING (K832865) | Sheridan Catheter Corp. | 1983-09-29 |
| DYNACOR CONNECTING TUBING (K832398) | Medline Industries, Inc. | 1983-08-24 |
Recalls involving this device
No recalls on record reference this clearance.