FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP
K Number: K910873
·
Decision May 29, 1991
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
209
Applicant Total
632
Review Days
89
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Basic Information
- Device Name
- BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP
- K Number
- K910873
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Date Received
- March 1, 1991
- Decision Date
- May 29, 1991
- Product Code
- DXT
- 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 |
|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | FDA class 2 | Cardiovascular |
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| K Number | Device Name | ||
|---|---|---|---|
| K003062 | BACTEC MGIT 960 SIR KITS | Jun 6, 2001 | Substantially Equivalent |
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| K003461 | BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE | Feb 1, 2001 | Substantially Equivalent |
| K002938 | B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 | Nov 29, 2000 | Substantially Equivalent |
| K001364 | BD DIRECTIGEN FLU A+B | Jun 28, 2000 | Substantially Equivalent |
| K000762 | MOXIFLOXACIN, 5 UG, BBL SENSI-DISC | Apr 25, 2000 | Substantially Equivalent |
| K000829 | GATIFLOXACIN, 5 UG, BBL SENSI-DISC | Apr 13, 2000 | Substantially Equivalent |
| K993186 | SYNERCID, 15 UG, BBL SENSI-DISC | Nov 3, 1999 | Substantially Equivalent |
| K992734 | BECTON DICKINSON SYRINGE | Oct 1, 1999 | Substantially Equivalent |
| K991551 | VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE | Sep 23, 1999 | Substantially Equivalent |