NRG TRANSSEPTAL NEEDLE— 510(k) K073326
Substantially EquivalentBaylis Medical Co., Inc.
FDA 510(k) clearance K073326 for NRG TRANSSEPTAL NEEDLE, Substantially Equivalent on 2008-05-28. Applicant: Baylis Medical Co., Inc.. Device class: 2.
Clearance details
- Applicant
- Baylis Medical Co., Inc.
- Product code
- Code DXF
- Device class
- Class 2
- Regulation
- 21 CFR 870.5175
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mississauga, Ontario, CA
Recent devices under product code DXF
view all- K261745 — LightningWire Transseptal Puncture System (TPS)
- K253799 — SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)
- K260292 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
- K252419 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
- K251007 — CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)
More clearances from Baylis Medical Co., Inc.
view allAdverse events under product code DXF
product code DXF- Death
- 78
- Injury
- 1,126
- Malfunction
- 507
- Other
- 1
- Total
- 1,712
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 K073326
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 K073326.
Data sourced from openFDA. This site is unofficial and independent of the FDA.