DeviceClearance

SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)— 510(k) K253799

Substantially Equivalent

Pressure Products Medical Device Manufacturing, LLC

FDA 510(k) clearance K253799 for SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R), Substantially Equivalent on 2026-03-13. Applicant: Pressure Products Medical Device Manufacturing, LLC. Device class: 2.

Summary

Pressure Products Medical Device Manufacturing's SafeSept RF Transseptal Guidewire is filed under DXF, septostomy catheters. The name lists eight model numbers: SSRF132, SSRF132R, SSRF232, SSRF232R, SSRF135, SSRF135R, SSRF235 and SSRF235R.

Class II, 21 CFR 870.5175. Cardiovascular is both the classification panel and the review panel. It was a Special 510(k).

Pressure Products Medical Device Manufacturing filed from Morton, Pennsylvania. The decision came 105 calendar days after receipt (November 28, 2025 to March 13, 2026).

Clearance details

Applicant
Pressure Products Medical Device Manufacturing, LLC
Product code
Product code DXF
Device class
Class 2
Regulation
21 CFR 870.5175
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Morton, PA, US
Download summary PDFView on FDA.gov ↗

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Adverse 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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.