FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDISYSTEMS APHERESIS NEEDLE WITH GUARD
K Number: K932074
·
Decision Feb 18, 1994
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
78
Applicant Total
22
Review Days
296
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Basic Information
- Device Name
- MEDISYSTEMS APHERESIS NEEDLE WITH GUARD
- K Number
- K932074
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medisystems Corp.
- Date Received
- April 28, 1993
- Decision Date
- February 18, 1994
- Product Code
- FIE
- 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 |
|---|---|---|---|
| FIE | Needle, Fistula | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FIE), ordered by most recent decision date.
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JMS Harmony A.V. Fistula Needle Set
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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 |