FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACUITY BREAK-AWAY GUIDE CATHETER
K Number: K093969
·
Decision Mar 5, 2010
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
76
Review Days
72
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Basic Information
- Device Name
- ACUITY BREAK-AWAY GUIDE CATHETER
- K Number
- K093969
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardiac Pacemakers, Inc.
- Date Received
- December 23, 2009
- Decision Date
- March 5, 2010
- 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 Cardiac Pacemakers, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K080154 | ACUITY UNIVERSAL CUTTER | Mar 20, 2008 | Substantially Equivalent |
| K934727 | REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER | Jan 10, 1994 | Substantially Equivalent |
| K920601 | ASTRA T2, ASTRA T4, ASTRA T6 | Oct 28, 1992 | Substantially Equivalent |
| K912379 | PDT CARRYALL TRANSMITTER, VARIOUS MODELS | Jun 17, 1991 | Substantially Equivalent |
| K905674 | LEAD STYLET | Jan 30, 1991 | Substantially Equivalent |
| K900498 | MODIFIED BETATRON IV INSULIN INFUSION SYSTEM | Feb 23, 1990 | Substantially Equivalent |
| K894738 | MODEL 6888 LEAD TUNNELER | Sep 13, 1989 | Substantially Equivalent |
| K890785 | ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE | Mar 10, 1989 | Substantially Equivalent |
| K875147 | TORQUE HEX WRENCH | Jan 27, 1988 | Substantially Equivalent |
| K872774 | BETATRON IV SYSTEM | Jan 5, 1988 | Substantially Equivalent |