FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CANDEKA DUKATIR SETS
K Number: K950635
·
Decision Mar 1, 1995
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
43
Review Days
16
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Basic Information
- Device Name
- CANDEKA DUKATIR SETS
- K Number
- K950635
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Candela Laser Corp.
- Date Received
- February 13, 1995
- Decision Date
- March 1, 1995
- 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 Candela Laser Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K951033 | ANDELA DYNAMIC COOLING DEVICE | Aug 15, 1996 | Substantially Equivalent |
| K955662 | CANDELA Q-SWITCHED ALEXANDRITE LASERS | Jun 14, 1996 | Substantially Equivalent |
| K955011 | CANDELA HCS 2000 URETHERAL WARMER CATHETER | Apr 3, 1996 | Substantially Equivalent |
| K954872 | CANDELA CRYO-PROBE HOLDER | Feb 5, 1996 | Substantially Equivalent |
| K954934 | CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE | Feb 2, 1996 | Substantially Equivalent |
| K953412 | CANDELA MODEL PLTL-1 LASER SYSTEM | Oct 24, 1995 | Substantially Equivalent |
| K953294 | CANDELA CRYOSYSTEM CS-5 | Oct 18, 1995 | Substantially Equivalent |
| K950831 | ALEXLAZR | May 26, 1995 | Substantially Equivalent |
| K946386 | CANDELA RUBY LAZE Q-SWITCHED RUBY LASER | Mar 24, 1995 | Substantially Equivalent |
| K950661 | CANDELA 10MM CIRCULAR SPOT LASER HANDPIECE | Mar 10, 1995 | Substantially Equivalent |