KWIK BOARD
FDA 510(k) clearance K930197 · decided 1993-04-20
Clearance details
- K-number
- K930197
- Device name
- KWIK BOARD
- Applicant
- Astral, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1993-01-14
- Decision date
- 1993-04-20
- Days to decision
- 96 days
- Clearance type
- Traditional
- Product code
- KMK
- Device class
- 1
- Regulation number
- 880.5210
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Rafael, CA, 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 |
|---|---|---|
| SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F (K180994) | Interrad Medical, Inc. | 2019-07-09 |
| A P HARNESS (K981860) | Paraworks Enterprise, Ltd. | 1999-06-03 |
| MULTI-PURPOSE MEDICAL TUBE HOLDER (K963365) | Byrd Medical Devices, Inc. | 1996-10-11 |
| SECURE-SITE (K941098) | Op-Co Medical Products , Ltd. | 1995-08-09 |
| STATLOCK CV (K943147) | Venetec, Inc. | 1994-09-29 |
| IV START KITS (K943047) | Sterile Concepts, Inc. | 1994-09-14 |
| IMMOBILE STERILE AND IMMOBILE A/C STERILE (K941940) | Tnt Moborg Intl. , Ltd. | 1994-07-14 |
| IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE (K941850) | Tnt Moborg Intl. , Ltd. | 1994-07-14 |
| CONMED VENI-GARD I.V. DRESSING (K935389) | Conmedcorp | 1994-03-07 |
| K-LOK CATHETER SECUREMENT DEVICE MODIFICATION (K935252) | K-Lok, Inc. | 1994-02-18 |
| CENTERMARK SECURING WINGS (K940127) | Menlo Care, Inc. | 1994-02-09 |
| SECURODRIP (TM) I.V. ARMBOARD (K932757) | Op-Co Medical Products , Ltd. | 1993-12-08 |
Recalls involving this device
No recalls on record reference this clearance.