Cryobag
FDA 510(k) K915471 · Janus Biomedical, Inc.
510(k) numberK915471
Submission
- Device name
- Cryobag
- Applicant
- Janus Biomedical, Inc.
Austin, TX, US - Received
- December 6, 1991
- Decision date
- March 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LPZ – Container, Frozen Donor Tissue Storage
- Device class
- Unclassified
Other 510(k)s with product code LPZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K021702 | Cryobag, Model CBLPZ · Traditional | Origen Biomedical, Inc. | 08/06/2002SE |
| K863872 | Tamper HamperLPZ · Traditional | Hydro-Med Products, Inc. | 02/10/1987SE |
| K861761 | Accessus Dry Storage Package Sterile Comp StorageLPZ · Traditional | Travenol Laboratories, S.A. | 08/28/1986SE |
| K860511 | Ampu-PakLPZ · Traditional | Ammerman Medical Enterprises, Inc. | 08/04/1986SE |
| K853663 | Accessus Cryopreservation Pkg. Sterile Tissue StorLPZ · Traditional | Travenol Laboratories, S.A. | 04/09/1986SE |
More from Travenol Laboratories, S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K943803 | Jostra HL-20 Integrated Perfusion SystemDTQ · Traditional | 01/30/1996SE |
Questions and answers
When was Cryobag cleared by the FDA?
Cryobag (K915471) received a 510(k) decision of Substantially Equivalent on March 2, 1994, 817 days after the submission was received.
What is the product code of K915471?
The FDA product code is LPZ – Container, Frozen Donor Tissue Storage, a Unclassified device.