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FDA 510(k)

NRG TRANSSEPTAL NEEDLE

K-Number: K073326 · 2008-05-28

ApplicantBaylis Medical Co., Inc.
Decision Date2008-05-28
Product CodeDXF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NRG TRANSSEPTAL NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Co., Inc.. It received FDA 510(k) clearance on 2008-05-28 under 510(k) number K073326. The device is classified under product code DXF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NRG TRANSSEPTAL NEEDLE?

NRG TRANSSEPTAL NEEDLE is a medical device that received FDA 510(k) clearance on 2008-05-28. The listed applicant is Baylis Medical Co., Inc.. The 510(k) number is K073326.

When did NRG TRANSSEPTAL NEEDLE receive FDA 510(k) clearance?

NRG TRANSSEPTAL NEEDLE received FDA 510(k) clearance on 2008-05-28, under 510(k) number K073326.

Who is the listed applicant for NRG TRANSSEPTAL NEEDLE?

The FDA 510(k) record lists Baylis Medical Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NRG TRANSSEPTAL NEEDLE?

The FDA product code for NRG TRANSSEPTAL NEEDLE is DXF.

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Other records listing Baylis Medical Co., Inc. as applicant

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K122926SUREFLEX STEERABLE GUIDING SHEATH KITK111523OSTEOCOOL (TM) RF ABLATION SYSTEMK102948TORFLEX TRANSSEPTAL GUIDING SHEATHK102192INDISCAL DIGITAL MANOMETERK101372DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20K101615POWERWIRE RADIOFREQUENCY GUIDEWIRE

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Related Devices (Code: DXF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261745LightningWire Transseptal Puncture System (TPS)ElectroWire MedicalK253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)Pressure Products Medical Device Manufacturing, LLCK260292HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)Atraverse MedicalK252419HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)Atraverse Medical, Inc.K251007CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)Circa Scientific, Inc.K243193Cross Wise™ Multi-Use RF Adapter CableCirca Scientific, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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