FDA 510(k)
FDA unclassified
Unknown
🇺🇸 United States
In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
K Number: K201165
·
Decision Dec 17, 2020
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
55
Applicant Total
54
Review Days
230
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Basic Information
- Device Name
- In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
- K Number
- K201165
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Coloplast Corp.
- Date Received
- May 1, 2020
- Decision Date
- December 17, 2020
- Product Code
- LJE
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LJE | Catheter, Nephrostomy | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LJE), ordered by most recent decision date.
Disposable Percutaneous Nephrostomy Dilatation Kit
FDA 510(k)
FDA Unclassified
·Unknown
Introducer Needle
FDA 510(k)
FDA Unclassified
·Unknown
Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets
FDA 510(k)
FDA Unclassified
·Unknown
Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
FDA 510(k)
FDA Unclassified
·Unknown
Lawson Retrograde Nephrostomy Wire Puncture Set
FDA 510(k)
FDA Unclassified
·Unknown
Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set
FDA 510(k)
FDA Unclassified
·Unknown
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