CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS— 510(k) K982891
Substantially EquivalentCalifornia Medical Laboratories, Inc.
FDA 510(k) clearance K982891 for CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS, Substantially Equivalent on 1998-09-30. Applicant: California Medical Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- California Medical Laboratories, Inc.
- Product code
- Code DTS
- Device class
- Class 2
- Regulation
- 21 CFR 870.4420
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code DTS
view allMore clearances from California Medical Laboratories, Inc.
view allRecalls naming K982891
K-number listed on FDA's recall record- Z-0649-2013 — Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.
- Z-0650-2013 — Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction Wands are indicated for use to remove excess fluid from the surgical field.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K982891.
Data sourced from openFDA. This site is unofficial and independent of the FDA.