FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
RIGHT ATRIAL CATHETER KITS
K Number: K920331
·
Decision Apr 22, 1992
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
36
Review Days
90
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Basic Information
- Device Name
- RIGHT ATRIAL CATHETER KITS
- K Number
- K920331
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Akcess Medical Products, Inc.
- Date Received
- January 23, 1992
- Decision Date
- April 22, 1992
- Product Code
- DQY
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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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 |
| K914826 | AKCESS-CATH KIT | Apr 10, 1992 | Unknown |
| K915215 | CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS | Mar 27, 1992 | Unknown |
| K911333 | RIGHT ATRIAL CATHETERS | Sep 23, 1991 | Substantially Equivalent |