FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
Sheath Introducer
K Number: K150932
·
Decision Jul 22, 2016
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
103
Applicant Total
11
Review Days
473
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Basic Information
- Device Name
- Sheath Introducer
- K Number
- K150932
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioteque Corp.
- Date Received
- April 6, 2015
- Decision Date
- July 22, 2016
- Product Code
- DRE
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | FDA class 2 | Cardiovascular |
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Other Clearances by Bioteque Corp.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K993118 | BIOTEQUE A.V. FISTULA NEEDLE SET | Dec 17, 1999 | Substantially Equivalent |
| K915491 | CURELLE | Nov 4, 1992 | Substantially Equivalent |