CRYOBAG, MODEL CB
FDA 510(k) clearance K021702 · decided 2002-08-06
Clearance details
- K-number
- K021702
- Device name
- CRYOBAG, MODEL CB
- Applicant
- Origen Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-05-23
- Decision date
- 2002-08-06
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- LPZ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Austin, TX, 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 |
|---|---|---|
| CRYOBAG (K915471) | Janus Biomedical, Inc. | 1994-03-02 |
| TAMPER HAMPER (K863872) | Hydro-Med Products, Inc. | 1987-02-10 |
| ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE (K861761) | Travenol Laboratories, S.A. | 1986-08-28 |
| AMPU-PAK (K860511) | Ammerman Medical Enterprises, Inc. | 1986-08-04 |
| ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR (K853663) | Travenol Laboratories, S.A. | 1986-04-09 |
Recalls involving this device
No recalls on record reference this clearance.