Route 92 Medical Full Length 070 Access System— 510(k) K222743
Substantially EquivalentRoute 92 Medical, Inc.
FDA 510(k) clearance K222743 for Route 92 Medical Full Length 070 Access System, Substantially Equivalent on 2022-10-04. Applicant: Route 92 Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Route 92 Medical, Inc.
- Product code
- Code QJP
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Mateo, CA, US
Recent devices under product code QJP
view allMore clearances from Route 92 Medical, Inc.
view all- K243601 — Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
- K240529 — 8F Modified Sheath System
- K233329 — Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set
- K231583 — Route 92 Medical Full Length 054 Access System
- K223530 — Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
Adverse events under product code QJP
product code QJP- Death
- 43
- Injury
- 233
- Malfunction
- 1,010
- Total
- 1,286
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 K222743
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K222743.
Data sourced from openFDA. This site is unofficial and independent of the FDA.