FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACKRAD MPR DRAINAGE CATHETER SET
K Number: K901574
·
Decision Jun 29, 1990
Classifications
1
FEI Numbers
242
Registration Numbers
243
Same Product Code
648
Applicant Total
42
Review Days
87
Basic Information
- Device Name
- ACKRAD MPR DRAINAGE CATHETER SET
- K Number
- K901574
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- ACKRAD LABORATORIES
- Date Received
- April 3, 1990
- Decision Date
- June 29, 1990
- Product Code
- KNT
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by ACKRAD LABORATORIES
| K Number | Device Name | ||
|---|---|---|---|
| K021272 | SIB CATHETER, MODEL 61-7005 | May 21, 2002 | Substantially Equivalent |
| K020954 | H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY | Apr 24, 2002 | Substantially Equivalent |
| K020951 | H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 | Apr 16, 2002 | Substantially Equivalent |
| K970492 | INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER | Apr 9, 1997 | Substantially Equivalent |
| K961752 | H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) | Aug 8, 1996 | Substantially Equivalent |
| K940176 | ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION | Apr 23, 1996 | Substantially Equivalent |
| K952542 | ACKRAD ESOPHAGEAL BALLOON CATHETER SET | Apr 23, 1996 | Substantially Equivalent |
| K953034 | H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) | Aug 29, 1995 | Substantially Equivalent |
| K915813 | ACKRAD ERCP CONTRAST DELIVERY SET | Mar 11, 1992 | Substantially Equivalent |
| K904499 | NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) | Jul 1, 1991 | Substantially Equivalent |