FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THORATEC GAS SAMPLING CONNECTOR
K Number: K822769
·
Decision Oct 6, 1982
Classifications
1
FEI Numbers
199
Registration Numbers
199
Same Product Code
183
Applicant Total
10
Review Days
22
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
- THORATEC GAS SAMPLING CONNECTOR
- K Number
- K822769
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5240
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Thoratec Laboratories Corp.
- Date Received
- September 14, 1982
- Decision Date
- October 6, 1982
- Product Code
- CAI
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAI), ordered by most recent decision date.
CONDENSATE COLLECTION KIT
FDA 510(k)
FDA Class 1
·Anesthesiology
UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT
FDA 510(k)
FDA Class 1
·Anesthesiology
UNICOR, INC. GAS SAMPLING LINES & CONNECTORS
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA COAXIAL CIRCUITS
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA ADULT GAS SAMPLING CIRCUITS
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA PEDIATRIC ANESTHESIA CIRCUITS
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Thoratec Laboratories Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K001927 | VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME | Dec 18, 2000 | Substantially Equivalent |
| K001926 | VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES | Sep 22, 2000 | Substantially Equivalent |
| K851495 | THORATEC MULTILUMEN CENTRAL VENOUS CATH-TRAY | Aug 1, 1985 | Unknown |
| K833714 | RESPIRATORY ASSESSMENT SYSTEM | Dec 29, 1983 | Substantially Equivalent |
| K833265 | RESPIRATORY FLOW MODULE | Nov 28, 1983 | Substantially Equivalent |
| K831557 | INTRAOPERATIVE AUTOTRANSFUSION SYS | Aug 24, 1983 | Substantially Equivalent |
| K823449 | RESPIRATORY GAS ANALYZER | Jan 5, 1983 | Substantially Equivalent |
| K823287 | RESPIRATORY CIRCUIT ADAPTOR | Dec 9, 1982 | Substantially Equivalent |
| K780247 | IMPCO DISPOSABLE AORTIC PUNCH | Feb 27, 1978 | Substantially Equivalent |