TSI Transseptal Introducer— 510(k) K181031
Substantially EquivalentPressure Products Medical Device Manufacturing, LLC
FDA 510(k) clearance K181031 for TSI Transseptal Introducer, Substantially Equivalent on 2018-10-26. Applicant: Pressure Products Medical Device Manufacturing, LLC. Device class: 2.
Clearance details
- Applicant
- Pressure Products Medical Device Manufacturing, LLC
- Product code
- Code DYB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morton, PA, US
Recent devices under product code DYB
view allMore clearances from Pressure Products Medical Device Manufacturing, LLC
view all- K253799 — SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)
- K241042 — SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
- K221707 — SafeSept® Transseptal Guidewire (SS-140)
- K210328 — SafeSept Blunt Needle
- K172950 — TSN Transseptal Needle
Adverse events under product code DYB
product code DYB- Death
- 808
- Injury
- 5,922
- Malfunction
- 16,516
- Other
- 5
- Total
- 23,251
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 K181031
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 K181031.
Data sourced from openFDA. This site is unofficial and independent of the FDA.