FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CUSTOM CORONARY MANIFOLD KITS
K Number: K853749
·
Decision Jan 13, 1986
Classifications
1
FEI Numbers
143
Registration Numbers
144
Same Product Code
136
Applicant Total
16
Review Days
126
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CUSTOM CORONARY MANIFOLD KITS
- K Number
- K853749
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4290
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Procedure Products, Inc.
- Date Received
- September 9, 1985
- Decision Date
- January 13, 1986
- Product Code
- DTL
- 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 |
|---|---|---|---|
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DTL), ordered by most recent decision date.
Attachable Cath Lab Hemostasis Valve
FDA 510(k)
FDA Class 2
·Cardiovascular
Passage Hemostasis Valve
FDA 510(k)
FDA Class 2
·Cardiovascular
ROTATING ADAPTERS
FDA 510(k)
FDA Class 2
·Cardiovascular
COLIGN
FDA 510(k)
FDA Class 2
·Cardiovascular
AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE
FDA 510(k)
FDA Class 2
·Cardiovascular
CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Procedure Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K161812 | Freedom Syringe | Mar 27, 2017 | Substantially Equivalent |
| 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 |
| K842173 | DISPOSABLE STOPCOCKS | Sep 5, 1984 | Substantially Equivalent |
| K833554 | MATERIAL ADDITION LEXAN & K-RESIN | Mar 12, 1984 | Substantially Equivalent |