Accessus Dry Storage Package Sterile Comp Storage
FDA 510(k) K861761 · Travenol Laboratories, S.A.
510(k) numberK861761
Submission
- Device name
- Accessus Dry Storage Package Sterile Comp Storage
- Applicant
- Travenol Laboratories, S.A.
Deerfield, IL, US - Received
- May 6, 1986
- Decision date
- August 28, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K915471 | CryobagLPZ · Traditional | Janus Biomedical, Inc. | 03/02/1994SE |
| K863872 | Tamper HamperLPZ · Traditional | Hydro-Med Products, Inc. | 02/10/1987SE |
| 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 |
|---|---|---|
| K874181 | Baxter Bedside SystemFRN · Traditional | 02/22/1988SE |
| K873894 | Continu-Flo Solution W/Check Valve 2 Y-Inject SiteFPA · Traditional | 11/05/1987SE |
| K873873 | Resubmitted Micron Transfusion FilterCAK · Traditional | 10/22/1987SE |
| K873984 | Automatic Peritoneal Dialysis Cycler Set (5C4437)KDJ · Traditional | 10/20/1987SE |
| K872364 | Hemodialysis (SPS), Model 550, Code 5M1309FII · Traditional | 10/13/1987SE |
| K872652 | Upgraded Auto Peritoneal Dialysis Cycler SystemFKX · Traditional | 09/30/1987SE |
| K870801 | Flo-Gard 6200 Volumetric Infusion/Pumping BloodFRN · Traditional | 09/04/1987SE |
| K871908 | IV Administration SetBRZ · Traditional | 07/27/1987SE |
| K871471 | Capillary Flow Dialyzers Models ST-12 & ST-15FJI · Traditional | 06/12/1987SE |
| K865029 | Continu-Flo Solution Admin. Set W/In-Line FilterFPB · Traditional | 04/17/1987SE |
Questions and answers
When was Accessus Dry Storage Package Sterile Comp Storage cleared by the FDA?
Accessus Dry Storage Package Sterile Comp Storage (K861761) received a 510(k) decision of Substantially Equivalent on August 28, 1986, 114 days after the submission was received.
What is the product code of K861761?
The FDA product code is LPZ – Container, Frozen Donor Tissue Storage, a Unclassified device.