SF SH CATHETER, MODEL R65-945— 510(k) K013437
Substantially EquivalentA & A Medical, Inc.
FDA 510(k) clearance K013437 for SF SH CATHETER, MODEL R65-945, Substantially Equivalent on 2001-11-19. Applicant: A & A Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- A & A Medical, Inc.
- Product code
- Code LKF
- Device class
- Class 2
- Regulation
- 21 CFR 884.4530
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alpharetta, GA, US
Recent devices under product code LKF
view allMore clearances from A & A Medical, Inc.
view all- K013491 — HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948
- K003949 — TACKER, MODEL R65-933
- K011512 — MMODIFICATION TO LAMINARIA
- K010510 — BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1
- K010789 — CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1
Adverse events under product code LKF
product code LKF- Malfunction
- 643
- Other
- 2
- Total
- 645
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.