FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOTEQUE A.V. FISTULA NEEDLE SET
K Number: K993118
·
Decision Dec 17, 1999
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
78
Applicant Total
11
Review Days
88
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Basic Information
- Device Name
- BIOTEQUE A.V. FISTULA NEEDLE SET
- K Number
- K993118
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioteque Corp.
- Date Received
- September 20, 1999
- Decision Date
- December 17, 1999
- 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.
JMS CAVEO A.V. Fistula Needle Set
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DORA Disposable A.V. Fistula Needle Sets
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Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
FDA 510(k)
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DORA Disposable A.V. Fistula Needle Sets
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FDA Class 2
·Gastroenterology, Urology
JMS Harmony A.V. Fistula Needle Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Bioteque Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K150932 | Sheath Introducer | Jul 22, 2016 | Substantially Equivalent |
| K102633 | BIOTEQ ANGIOGRAPHIC CATHETER | Sep 9, 2011 | Substantially Equivalent |
| K033862 | BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK | Feb 14, 2005 | Substantially Equivalent |
| K033210 | BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET | Dec 30, 2004 | Substantially Equivalent |
| K032292 | BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX | Mar 22, 2004 | Substantially Equivalent |
| K013634 | BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK | Jul 9, 2002 | Unknown |
| K012526 | BIOTEQUE SCALP VEIN SET | Sep 14, 2001 | Substantially Equivalent |
| K002449 | BIOTEQ I.V. (INTRAVENOUS) SET | Dec 22, 2000 | Substantially Equivalent |
| K992930 | BIOTEQUE HEMODIALYSIS BLOOD TUBING SET | Feb 9, 2000 | Substantially Equivalent |
| K915491 | CURELLE | Nov 4, 1992 | Substantially Equivalent |