FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BURRON TEFLON-COATED GUIDEWIRE
K Number: K884183
·
Decision Aug 3, 1989
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
9
Review Days
303
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Basic Information
- Device Name
- BURRON TEFLON-COATED GUIDEWIRE
- K Number
- K884183
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Burron Medical, Inc.
- Date Received
- October 4, 1988
- Decision Date
- August 3, 1989
- Product Code
- DQX
- 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Burron Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K902401 | CELSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM | Oct 8, 1991 | Substantially Equivalent |
| K896422 | BURRON AMBULATORY DRUG DELIVERY SYSTEM | May 9, 1990 | Substantially Equivalent |
| K884235 | COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KIT | Mar 6, 1990 | Substantially Equivalent |
| K895191 | ANTI-THROMBOGENIC COATING FOR CATHETERS | Nov 24, 1989 | Substantially Equivalent |
| K895192 | SPINOCAN(R) CONTINUOUS SPINAL TRAY | Sep 18, 1989 | Substantially Equivalent |
| K882106 | PERFUSOR M SYRINGE PUMP | Aug 11, 1988 | Substantially Equivalent |
| K882107 | PERFUSOR SECURA SYRINGE PUMP | Aug 11, 1988 | Substantially Equivalent |
| K881342 | IMPLANTOFIX II IMPLANTABLE DRUG DELIVERY SYSTEM | Aug 9, 1988 | Substantially Equivalent |