FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NORTA TEFLON COATED LATEX BALLOON CATHETERS
K Number: K861181
·
Decision Apr 8, 1986
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
237
Applicant Total
45
Review Days
8
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Basic Information
- Device Name
- NORTA TEFLON COATED LATEX BALLOON CATHETERS
- K Number
- K861181
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Beiersdorf, Inc.
- Date Received
- March 31, 1986
- Decision Date
- April 8, 1986
- Product Code
- KOD
- 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 |
|---|---|---|---|
| KOD | Catheter, Urological | FDA class 2 | Gastroenterology, Urology |
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| K Number | Device Name | ||
|---|---|---|---|
| K090921 | ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02 | Dec 18, 2009 | Substantially Equivalent |
| K024057 | CURAD SCAR THERAPY | Jun 18, 2003 | Substantially Equivalent |
| K952526 | CUTINOVA CAVITY | Aug 14, 1995 | Substantially Equivalent for Some Indications |
| K943363 | CUTIPLAST STERIL | Mar 15, 1995 | Substantially Equivalent |
| K944581 | CUTINOVA THIN WOUND DRESSING | Dec 2, 1994 | Substantially Equivalent for Some Indications |
| K935630 | NORTA | Oct 7, 1994 | Substantially Equivalent |
| K940378 | COVERLET ADHESIVE DRESSING | Jul 29, 1994 | Substantially Equivalent for Some Indications |
| K925630 | ELASTOPLAST HEAT PLASTER | Feb 25, 1994 | Substantially Equivalent |
| K926399 | CUTIFILM(R) FILM | Nov 15, 1993 | Substantially Equivalent |
| K923404 | LUEKOFLEX SURGICAL TAPE | Sep 9, 1992 | Substantially Equivalent |