FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR
K Number: K853663
·
Decision Apr 9, 1986
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
5
Applicant Total
206
Review Days
218
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR
- K Number
- K853663
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Travenol Laboratories, S.A.
- Date Received
- September 3, 1985
- Decision Date
- April 9, 1986
- Product Code
- LPZ
- Advisory Committee
- Unknown
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPZ | Container, Frozen Donor Tissue Storage | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LPZ), ordered by most recent decision date.
CRYOBAG, MODEL CB
FDA 510(k)
FDA Unclassified
·Unknown
CRYOBAG
FDA 510(k)
FDA Unclassified
·Unknown
TAMPER HAMPER
FDA 510(k)
FDA Unclassified
·Unknown
ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE
FDA 510(k)
FDA Unclassified
·Unknown
AMPU-PAK
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Travenol Laboratories, S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K874181 | BAXTER BEDSIDE SYSTEM | Feb 22, 1988 | Substantially Equivalent |
| K873894 | CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE | Nov 5, 1987 | Substantially Equivalent |
| K873873 | RESUBMITTED MICRON TRANSFUSION FILTER | Oct 22, 1987 | Substantially Equivalent |
| K873984 | AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437) | Oct 20, 1987 | Substantially Equivalent |
| K872364 | HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 | Oct 13, 1987 | Substantially Equivalent |
| K872652 | UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM | Sep 30, 1987 | Substantially Equivalent |
| K870801 | FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD | Sep 4, 1987 | Substantially Equivalent |
| K871908 | IV ADMINISTRATION SET | Jul 27, 1987 | Substantially Equivalent |
| K871471 | CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 | Jun 12, 1987 | Substantially Equivalent |
| K865029 | CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER | Apr 17, 1987 | Substantially Equivalent |