FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDISYSTEMS TRANSDUCER PROTECTOR
K Number: K895856
·
Decision Nov 24, 1989
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
34
Applicant Total
22
Review Days
53
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
- MEDISYSTEMS TRANSDUCER PROTECTOR
- K Number
- K895856
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Medisystems Corp.
- Date Received
- October 2, 1989
- Decision Date
- November 24, 1989
- Product Code
- FIB
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FIB | Protector, Transducer, Dialysis | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FIB), ordered by most recent decision date.
NovaLine SP-C35 Transducer Protector (956007)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HEMODIALYSIS TUBING SETS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Medisystems Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K062953 | MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE | Feb 12, 2007 | Substantially Equivalent |
| K010279 | MEDISYSTEMS LUER ACCESS INJECTION SITE | May 29, 2001 | Substantially Equivalent |
| K002372 | ACCESS ALERT GAUGE | Oct 25, 2000 | Substantially Equivalent |
| K994306 | REVERSO | Mar 20, 2000 | Substantially Equivalent |
| K990803 | MEDISYSTEMS BUTTONHOLE NEEDLE SETS | Jan 6, 2000 | Substantially Equivalent |
| K983076 | MEDISYSTEMS TRANSDUCER PROTECTOR | Nov 25, 1998 | Substantially Equivalent |
| K971860 | MEDISYSTEMS DIALYSIS PRIMING SETS | Aug 18, 1997 | Substantially Equivalent |
| K963668 | MEDISYSTEMS PERITONEAL DIALYSIS SETS | Aug 15, 1997 | Substantially Equivalent |
| K970536 | MEDISYSTEMS TRANDUCER PROTECTOR | May 12, 1997 | Substantially Equivalent |
| K953823 | ARTERIAL VENOUS BLOOD TUBING SET | Sep 23, 1996 | Substantially Equivalent |