MEDRAD COUNTERPOISE SYSTEM— 510(k) K944983
Substantially EquivalentMedrad, Inc.
FDA 510(k) clearance K944983 for MEDRAD COUNTERPOISE SYSTEM, Substantially Equivalent on 1994-11-29. Applicant: Medrad, Inc.. Device class: 2.
Clearance details
- Applicant
- Medrad, Inc.
- Product code
- Code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pittsburgh, PA, US
Recent devices under product code JAK
view allMore clearances from Medrad, Inc.
view all- K133023 — JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6
- K130381 — ANGIOJET ULTRA POWER PULSE KIT
- K130637 — JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM
- K122916 — JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM
- K113363 — ANGIOJET SOLENT DISTA THROMBECTOMY SET
Adverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
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 →
Recalls naming K944983
K-number listed on FDA's recall record- Z-2960-2018 — Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253
- Z-2961-2018 — Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a support for an injector head. , SHORT CEIL MNT, STD HORZ ARM, Catalog # OCS 115AS, Material Number 59880288
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K944983.
Data sourced from openFDA. This site is unofficial and independent of the FDA.