FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTRODUCER NEEDLES
K Number: K910641
·
Decision Apr 29, 1991
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
181
Applicant Total
36
Review Days
75
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Basic Information
- Device Name
- INTRODUCER NEEDLES
- K Number
- K910641
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Akcess Medical Products, Inc.
- Date Received
- February 13, 1991
- Decision Date
- April 29, 1991
- Product Code
- KOC
- 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 |
|---|---|---|---|
| KOC | Accessories, Blood Circuit, Hemodialysis | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)
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BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU
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CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line
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CAREline Airless Hemodialysis Blood Tubing Sets
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Other Clearances by Akcess Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K926374 | SILICONE CATHETER REPAIR KITS | Oct 7, 1994 | Unknown |
| K925819 | AKCESS0CATH KIT | Aug 2, 1994 | Substantially Equivalent |
| K925818 | AKCESS-CATH | Apr 5, 1994 | Substantially Equivalent |
| K930630 | RIGHT ATRIAL CATHETER | Feb 7, 1994 | Substantially Equivalent for Some Indications |
| K920634 | SPLITTABLE SHEATH INTRODUCER SET | Jan 14, 1994 | Substantially Equivalent |
| K931120 | COAXIAL ACUTE CATHETER | Jan 14, 1994 | Substantially Equivalent |
| K914936 | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH SET | Apr 23, 1992 | Unknown |
| K920331 | RIGHT ATRIAL CATHETER KITS | Apr 22, 1992 | Unknown |
| K914826 | AKCESS-CATH KIT | Apr 10, 1992 | Unknown |
| K915215 | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS | Mar 27, 1992 | Unknown |