FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SINGLE USE SELDINGER/COURNAND PERC. NDL
K Number: K810859
·
Decision Apr 11, 1981
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
102
Applicant Total
15
Review Days
12
Basic Information
- Device Name
- SINGLE USE SELDINGER/COURNAND PERC. NDL
- K Number
- K810859
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- PROCEDURE PRODUCTS, INC.
- Date Received
- March 30, 1981
- Decision Date
- April 11, 1981
- Product Code
- DRE
- 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 |
|---|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRE), ordered by most recent decision date.
VersaCross Connect Transseptal Dilator
FDA 510(k)
FDA Class 2
·Cardiovascular
Micro Ace Gold Advanced Micro Access System
FDA 510(k)
FDA Class 2
·Cardiovascular
VersaCross Connect Transseptal Dilator
FDA 510(k)
FDA Class 2
·Cardiovascular
VersaCross Connect Transseptal Dilator
FDA 510(k)
FDA Class 2
·Cardiovascular
Micro Ace Advanced Micro Access System
FDA 510(k)
FDA Class 2
·Cardiovascular
TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by PROCEDURE PRODUCTS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K923194 | INSUFFLATOR CONNECTING FILTER | Oct 8, 1993 | Substantially Equivalent |
| K922536 | TORQUE DEVICE | Dec 10, 1992 | Substantially Equivalent |
| K914128 | CONNECTING SET | Nov 27, 1991 | Substantially Equivalent |
| K910673 | BAG SPIGOT | Apr 24, 1991 | Substantially Equivalent |
| K884985 | MODIFIED 10CC SYRINGE CONTROL RING SET | Dec 20, 1988 | Substantially Equivalent |
| K874747 | 10CC SYRINGE CONTROL RING SET | Feb 4, 1988 | Substantially Equivalent |
| K874037 | ANGIO WASTE FLUIDS DUMP BAG | Jan 29, 1988 | Substantially Equivalent |
| K853749 | CUSTOM CORONARY MANIFOLD KITS | Jan 13, 1986 | Substantially Equivalent |
| K842173 | DISPOSABLE STOPCOCKS | Sep 5, 1984 | Substantially Equivalent |
| K833554 | MATERIAL ADDITION LEXAN & K-RESIN | Mar 12, 1984 | Substantially Equivalent |