FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
USCI DORROS INFUSION/PROBING CATHETER
K Number: K884209
·
Decision Dec 21, 1988
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
12
Review Days
76
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Basic Information
- Device Name
- USCI DORROS INFUSION/PROBING CATHETER
- K Number
- K884209
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Usci, Div. C.R. Bard, Inc.
- Date Received
- October 6, 1988
- Decision Date
- December 21, 1988
- 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 Usci, Div. C.R. Bard, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K940092 | USCI INPUT INTRODUCER SET | Aug 10, 1995 | Substantially Equivalent |
| K771823 | CATHETER, CARDIOVASCULAR | Dec 20, 1977 | Substantially Equivalent |
| K771982 | 888 ARTERIAL/VENOUS CATHETER INTRODUCER | Nov 2, 1977 | Substantially Equivalent |
| K772021 | TRC STAINLESS STEEL SAFETY SPRING GUIDES | Nov 2, 1977 | Substantially Equivalent |
| K770835 | PATCH FABRIC | Oct 5, 1977 | Substantially Equivalent |
| K770561 | CATHETER,PERCUTANEOUS INTRODUC. & SHEATH | Apr 26, 1977 | Substantially Equivalent |
| K770236 | SAUVAGE FILAMENTOUS PROSTHESES | Feb 25, 1977 | Substantially Equivalent |
| K770235 | DEBAKEY VASCULOUR-D PROSTHESES | Feb 24, 1977 | Substantially Equivalent |
| K760843 | PALEY TRANSPARENT MANIFOLD | Nov 12, 1976 | Substantially Equivalent |
| K760403 | TEMPORARY ATRIAL ELECTRODE KIT | Aug 23, 1976 | Substantially Equivalent |