HIGH PRESSURE INJECTION LINES— 510(k) K963749
Substantially EquivalentMaxxim Medical
FDA 510(k) clearance K963749 for HIGH PRESSURE INJECTION LINES, Substantially Equivalent on 1996-12-17. Applicant: Maxxim Medical. Device class: 2.
Clearance details
- Applicant
- Maxxim Medical
- Product code
- Code DTL
- Device class
- Class 2
- Regulation
- 21 CFR 870.4290
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Worth, TX, US
Recent devices under product code DTL
view allMore clearances from Maxxim Medical
view all- K023236 — SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES
- K021452 — STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVE
- K011905 — SNIPER ELITE MODEL-OR-E3872XX SERIES
- K002847 — INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX
- K010297 — SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE)
Adverse events under product code DTL
product code DTL- Malfunction
- 770
- Total
- 770
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.